Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells
Identifieur interne : 001218 ( Istex/Corpus ); précédent : 001217; suivant : 001219Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells
Auteurs : Leopold Grillberger ; Thomas R. Kreil ; Sonia Nasr ; Manfred ReiterSource :
- Biotechnology Journal [ 1860-6768 ] ; 2009-02.
English descriptors
- Teeft :
- Additive, Advate, Amino acids, Animal components, Animal products, Animal proteins, Biol chem, Biologics evaluation, Biopharmaceutical, Biopharmaceutical manufacturing, Biopharmaceuticals, Biotechnol, Biotechnology, Biotechnology journal, Biotechnology journal biotechnol, Blood products, Blood safety, Blood supply, Blood transfusion, Bovine spongiform encephalopathy, Cell culture, Cell culture media, Cell culture medium, Cell culture process, Cell line, Cell lines, Cell substrates, Chinese hamster ovary, Chinese hamster ovary cells, Chronic diseases, Clinical outcomes, Coagulation factor viii, Cumulative risk, Different formulations, Disease control, Drug administration, European union, Factor viii, Factor viii replacement therapy, Final formulation, Fviii, Fviii product, Glycosylation, Glycosylation patterns, Gmbh, Growth factors, Haemophilia, Hemophilia, Hemophilia patients, High risk, Human growth hormone, Human herpesvirus, Human immunodeficiency virus, Human parvovirus, Human proteins, Human serum albumin, Hybridoma, Hybridoma cells, Iatrogenic transmission, Immunogenicity, Inactivation, Infectious agents, Infectious diseases, Kgaa, Lancet, Lower immunogenicity, Mammalian cell lines, Mammalian cells, Manfred reiter, Manufacturing process, Monoclonal antibody, National hemophilia foundation, Neurol neurosurg psychiatry, Nucleic acid amplification testing, Parvovirus, Parvovirus parv4, Pathogen, Pathogen transmission, Patient compliance, Phase iiib study, Plasma derivatives, Plasma proteins, Possible transmission, Prion, Process development, Product expression system, Protein, Protein misfolding, Protein therapeutics, Recent years, Recombinant, Recombinant factor viii, Recombinant fviii, Recombinant fviii products, Recombinant products, Recombinant protein therapeutics, Recombinant proteins, Regulatory agencies, Regulatory concerns, Regulatory requirements, Removal steps, Respiratory syndrome, Safety issues, Seite, Semin hematol, Serum albumin, Serum components, Serum proteins, Special risk, Surface adsorption, Therapeutic products, Therapeutic proteins, Therapeutics, Transfusion, Transmissible spongiform encephalopathies, Tumor necrosis factor, Vaccine, Variant disease, Vast majority, Vcjd, Vcjd transmission, Verlag, Verlag gmbh, Viii, Weinheim, Weinheim biotechnol, West nile virus.
Abstract
Mammalian cells are the expression system of choice for therapeutic proteins, especially those requiring complex post‐translational modifications. Traditionally, these cells are grown in medium supplemented with serum and other animal‐ or human‐derived components to support viability and productivity. Such proteins are also typically added as excipients and stabilizers in the final drug formulation. However, the transmission of hepatitis B in the 1970s and of hepatitis C and HIV in the 1980s through plasma‐derived factor VIII concentrates had catastrophic consequences for hemophilia patients. Thus, due to regulatory concerns about the inherent potential for transmission of infectious agents as well as the heterogeneity and lack of reliability of the serum supply, a trend has emerged to eliminate the use of plasma‐derived additives in the production and formulation of recombinant protein therapeutics. This practice began with products used in the treatment of hemophilia and is progressively expanding throughout the entire industry. The plasma‐free method of producing recombinant therapeutics is accomplished by the use of both cell culture media and final product formulations that do not contain animal‐ or human‐derived additives. A number of recombinant therapeutic proteins for the treatment of several different diseases have been produced by plasma‐free processes, with the objective of improving safety by eliminating blood‐borne pathogens or by reducing immunogenicity. This review describes the factors that drove the development of plasma‐free protein therapeutics and provides examples of advances in manufacturing that have made possible the removal of human and animal‐derived products from all steps of recombinant protein production.
Url:
DOI: 10.1002/biot.200800241
Links to Exploration step
ISTEX:E40FB9671119F56E8D2E3BE8E8E531FACEEB1163Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells</title><author><name sortKey="Grillberger, Leopold" sort="Grillberger, Leopold" uniqKey="Grillberger L" first="Leopold" last="Grillberger">Leopold Grillberger</name><affiliation><mods:affiliation>Baxter BioScience, Vienna, Austria</mods:affiliation></affiliation></author><author><name sortKey="Kreil, Thomas R" sort="Kreil, Thomas R" uniqKey="Kreil T" first="Thomas R." last="Kreil">Thomas R. Kreil</name><affiliation><mods:affiliation>Baxter BioScience, Vienna, Austria</mods:affiliation></affiliation></author><author><name sortKey="Nasr, Sonia" sort="Nasr, Sonia" uniqKey="Nasr S" first="Sonia" last="Nasr">Sonia Nasr</name><affiliation><mods:affiliation>Therapy Management Specialists, Inc., Broomfield, CO, USA</mods:affiliation></affiliation></author><author><name sortKey="Reiter, Manfred" sort="Reiter, Manfred" uniqKey="Reiter M" first="Manfred" last="Reiter">Manfred Reiter</name><affiliation><mods:affiliation>Baxter BioScience, Vienna, Austria</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: manfred_reiter@baxter.com</mods:affiliation></affiliation><affiliation><mods:affiliation>Correspondence address: R & D Upstream Process Development, Baxter Innovations GmbH, Industriestrasse 67, 1221 Vienna, Austria, +43‐1‐20100‐4693</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:E40FB9671119F56E8D2E3BE8E8E531FACEEB1163</idno><date when="2009" year="2009">2009</date><idno type="doi">10.1002/biot.200800241</idno><idno type="url">https://api.istex.fr/ark:/67375/WNG-GRH0PWQM-Q/fulltext.pdf</idno><idno type="wicri:Area/Istex/Corpus">001218</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001218</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main">Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells</title><author><name sortKey="Grillberger, Leopold" sort="Grillberger, Leopold" uniqKey="Grillberger L" first="Leopold" last="Grillberger">Leopold Grillberger</name><affiliation><mods:affiliation>Baxter BioScience, Vienna, Austria</mods:affiliation></affiliation></author><author><name sortKey="Kreil, Thomas R" sort="Kreil, Thomas R" uniqKey="Kreil T" first="Thomas R." last="Kreil">Thomas R. Kreil</name><affiliation><mods:affiliation>Baxter BioScience, Vienna, Austria</mods:affiliation></affiliation></author><author><name sortKey="Nasr, Sonia" sort="Nasr, Sonia" uniqKey="Nasr S" first="Sonia" last="Nasr">Sonia Nasr</name><affiliation><mods:affiliation>Therapy Management Specialists, Inc., Broomfield, CO, USA</mods:affiliation></affiliation></author><author><name sortKey="Reiter, Manfred" sort="Reiter, Manfred" uniqKey="Reiter M" first="Manfred" last="Reiter">Manfred Reiter</name><affiliation><mods:affiliation>Baxter BioScience, Vienna, Austria</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: manfred_reiter@baxter.com</mods:affiliation></affiliation><affiliation><mods:affiliation>Correspondence address: R & D Upstream Process Development, Baxter Innovations GmbH, Industriestrasse 67, 1221 Vienna, Austria, +43‐1‐20100‐4693</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Biotechnology Journal</title><title level="j" type="sub">Cell and Protein Manipulation</title><title level="j" type="alt">BIOTECHNOLOGY JOURNAL</title><idno type="ISSN">1860-6768</idno><idno type="eISSN">1860-7314</idno><imprint><biblScope unit="vol">4</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="186">186</biblScope><biblScope unit="page" to="201">201</biblScope><biblScope unit="page-count">16</biblScope><publisher>WILEY‐VCH Verlag</publisher><pubPlace>Weinheim</pubPlace><date type="published" when="2009-02">2009-02</date></imprint><idno type="ISSN">1860-6768</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1860-6768</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Additive</term><term>Advate</term><term>Amino acids</term><term>Animal components</term><term>Animal products</term><term>Animal proteins</term><term>Biol chem</term><term>Biologics evaluation</term><term>Biopharmaceutical</term><term>Biopharmaceutical manufacturing</term><term>Biopharmaceuticals</term><term>Biotechnol</term><term>Biotechnology</term><term>Biotechnology journal</term><term>Biotechnology journal biotechnol</term><term>Blood products</term><term>Blood safety</term><term>Blood supply</term><term>Blood transfusion</term><term>Bovine spongiform encephalopathy</term><term>Cell culture</term><term>Cell culture media</term><term>Cell culture medium</term><term>Cell culture process</term><term>Cell line</term><term>Cell lines</term><term>Cell substrates</term><term>Chinese hamster ovary</term><term>Chinese hamster ovary cells</term><term>Chronic diseases</term><term>Clinical outcomes</term><term>Coagulation factor viii</term><term>Cumulative risk</term><term>Different formulations</term><term>Disease control</term><term>Drug administration</term><term>European union</term><term>Factor viii</term><term>Factor viii replacement therapy</term><term>Final formulation</term><term>Fviii</term><term>Fviii product</term><term>Glycosylation</term><term>Glycosylation patterns</term><term>Gmbh</term><term>Growth factors</term><term>Haemophilia</term><term>Hemophilia</term><term>Hemophilia patients</term><term>High risk</term><term>Human growth hormone</term><term>Human herpesvirus</term><term>Human immunodeficiency virus</term><term>Human parvovirus</term><term>Human proteins</term><term>Human serum albumin</term><term>Hybridoma</term><term>Hybridoma cells</term><term>Iatrogenic transmission</term><term>Immunogenicity</term><term>Inactivation</term><term>Infectious agents</term><term>Infectious diseases</term><term>Kgaa</term><term>Lancet</term><term>Lower immunogenicity</term><term>Mammalian cell lines</term><term>Mammalian cells</term><term>Manfred reiter</term><term>Manufacturing process</term><term>Monoclonal antibody</term><term>National hemophilia foundation</term><term>Neurol neurosurg psychiatry</term><term>Nucleic acid amplification testing</term><term>Parvovirus</term><term>Parvovirus parv4</term><term>Pathogen</term><term>Pathogen transmission</term><term>Patient compliance</term><term>Phase iiib study</term><term>Plasma derivatives</term><term>Plasma proteins</term><term>Possible transmission</term><term>Prion</term><term>Process development</term><term>Product expression system</term><term>Protein</term><term>Protein misfolding</term><term>Protein therapeutics</term><term>Recent years</term><term>Recombinant</term><term>Recombinant factor viii</term><term>Recombinant fviii</term><term>Recombinant fviii products</term><term>Recombinant products</term><term>Recombinant protein therapeutics</term><term>Recombinant proteins</term><term>Regulatory agencies</term><term>Regulatory concerns</term><term>Regulatory requirements</term><term>Removal steps</term><term>Respiratory syndrome</term><term>Safety issues</term><term>Seite</term><term>Semin hematol</term><term>Serum albumin</term><term>Serum components</term><term>Serum proteins</term><term>Special risk</term><term>Surface adsorption</term><term>Therapeutic products</term><term>Therapeutic proteins</term><term>Therapeutics</term><term>Transfusion</term><term>Transmissible spongiform encephalopathies</term><term>Tumor necrosis factor</term><term>Vaccine</term><term>Variant disease</term><term>Vast majority</term><term>Vcjd</term><term>Vcjd transmission</term><term>Verlag</term><term>Verlag gmbh</term><term>Viii</term><term>Weinheim</term><term>Weinheim biotechnol</term><term>West nile virus</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Mammalian cells are the expression system of choice for therapeutic proteins, especially those requiring complex post‐translational modifications. Traditionally, these cells are grown in medium supplemented with serum and other animal‐ or human‐derived components to support viability and productivity. Such proteins are also typically added as excipients and stabilizers in the final drug formulation. However, the transmission of hepatitis B in the 1970s and of hepatitis C and HIV in the 1980s through plasma‐derived factor VIII concentrates had catastrophic consequences for hemophilia patients. Thus, due to regulatory concerns about the inherent potential for transmission of infectious agents as well as the heterogeneity and lack of reliability of the serum supply, a trend has emerged to eliminate the use of plasma‐derived additives in the production and formulation of recombinant protein therapeutics. This practice began with products used in the treatment of hemophilia and is progressively expanding throughout the entire industry. The plasma‐free method of producing recombinant therapeutics is accomplished by the use of both cell culture media and final product formulations that do not contain animal‐ or human‐derived additives. A number of recombinant therapeutic proteins for the treatment of several different diseases have been produced by plasma‐free processes, with the objective of improving safety by eliminating blood‐borne pathogens or by reducing immunogenicity. This review describes the factors that drove the development of plasma‐free protein therapeutics and provides examples of advances in manufacturing that have made possible the removal of human and animal‐derived products from all steps of recombinant protein production.</div></front></TEI><istex><corpusName>wiley</corpusName><keywords><teeft><json:string>recombinant</json:string><json:string>pathogen</json:string><json:string>hemophilia</json:string><json:string>biotechnol</json:string><json:string>viii</json:string><json:string>fviii</json:string><json:string>prion</json:string><json:string>vcjd</json:string><json:string>gmbh</json:string><json:string>transfusion</json:string><json:string>kgaa</json:string><json:string>weinheim</json:string><json:string>verlag gmbh</json:string><json:string>seite</json:string><json:string>verlag</json:string><json:string>biotechnology</json:string><json:string>therapeutics</json:string><json:string>haemophilia</json:string><json:string>blood transfusion</json:string><json:string>immunogenicity</json:string><json:string>factor viii</json:string><json:string>pathogen transmission</json:string><json:string>blood supply</json:string><json:string>biopharmaceutical</json:string><json:string>biopharmaceuticals</json:string><json:string>therapeutic proteins</json:string><json:string>manufacturing process</json:string><json:string>cell culture</json:string><json:string>parvovirus</json:string><json:string>hybridoma</json:string><json:string>advate</json:string><json:string>lancet</json:string><json:string>glycosylation</json:string><json:string>cell lines</json:string><json:string>blood products</json:string><json:string>variant disease</json:string><json:string>infectious agents</json:string><json:string>biopharmaceutical manufacturing</json:string><json:string>recombinant products</json:string><json:string>weinheim biotechnol</json:string><json:string>regulatory agencies</json:string><json:string>cell line</json:string><json:string>recombinant proteins</json:string><json:string>vaccine</json:string><json:string>animal proteins</json:string><json:string>mammalian cells</json:string><json:string>protein therapeutics</json:string><json:string>semin hematol</json:string><json:string>recombinant protein therapeutics</json:string><json:string>infectious diseases</json:string><json:string>human serum albumin</json:string><json:string>monoclonal antibody</json:string><json:string>national hemophilia foundation</json:string><json:string>glycosylation patterns</json:string><json:string>plasma proteins</json:string><json:string>vcjd transmission</json:string><json:string>blood safety</json:string><json:string>hemophilia patients</json:string><json:string>serum albumin</json:string><json:string>process development</json:string><json:string>recombinant factor viii</json:string><json:string>cell culture media</json:string><json:string>serum components</json:string><json:string>human growth hormone</json:string><json:string>cell culture medium</json:string><json:string>lower immunogenicity</json:string><json:string>additive</json:string><json:string>protein</json:string><json:string>bovine spongiform encephalopathy</json:string><json:string>biotechnology journal biotechnol</json:string><json:string>serum proteins</json:string><json:string>growth factors</json:string><json:string>parvovirus parv4</json:string><json:string>recombinant fviii products</json:string><json:string>cell culture process</json:string><json:string>fviii product</json:string><json:string>recombinant fviii</json:string><json:string>therapeutic products</json:string><json:string>factor viii replacement therapy</json:string><json:string>human proteins</json:string><json:string>west nile virus</json:string><json:string>tumor necrosis factor</json:string><json:string>respiratory syndrome</json:string><json:string>hybridoma cells</json:string><json:string>nucleic acid amplification testing</json:string><json:string>human immunodeficiency virus</json:string><json:string>human herpesvirus</json:string><json:string>coagulation factor viii</json:string><json:string>drug administration</json:string><json:string>transmissible spongiform encephalopathies</json:string><json:string>chinese hamster ovary</json:string><json:string>regulatory requirements</json:string><json:string>disease control</json:string><json:string>iatrogenic transmission</json:string><json:string>biologics evaluation</json:string><json:string>safety issues</json:string><json:string>animal components</json:string><json:string>different formulations</json:string><json:string>amino acids</json:string><json:string>surface adsorption</json:string><json:string>plasma derivatives</json:string><json:string>clinical outcomes</json:string><json:string>phase iiib study</json:string><json:string>chronic diseases</json:string><json:string>cumulative risk</json:string><json:string>special risk</json:string><json:string>manfred reiter</json:string><json:string>patient compliance</json:string><json:string>vast majority</json:string><json:string>removal steps</json:string><json:string>mammalian cell lines</json:string><json:string>final formulation</json:string><json:string>european union</json:string><json:string>high risk</json:string><json:string>recent years</json:string><json:string>protein misfolding</json:string><json:string>product expression system</json:string><json:string>biotechnology journal</json:string><json:string>regulatory concerns</json:string><json:string>human parvovirus</json:string><json:string>possible transmission</json:string><json:string>chinese hamster ovary cells</json:string><json:string>neurol neurosurg psychiatry</json:string><json:string>biol chem</json:string><json:string>animal products</json:string><json:string>cell substrates</json:string><json:string>inactivation</json:string></teeft></keywords><author><json:item><name>Leopold Grillberger</name><affiliations><json:string>Baxter BioScience, Vienna, Austria</json:string></affiliations></json:item><json:item><name>Thomas R. Kreil</name><affiliations><json:string>Baxter BioScience, Vienna, Austria</json:string></affiliations></json:item><json:item><name>Sonia Nasr</name><affiliations><json:string>Therapy Management Specialists, Inc., Broomfield, CO, USA</json:string></affiliations></json:item><json:item><name>Manfred Reiter</name><affiliations><json:string>Baxter BioScience, Vienna, Austria</json:string><json:string>E-mail: manfred_reiter@baxter.com</json:string><json:string>Correspondence address: R & D Upstream Process Development, Baxter Innovations GmbH, Industriestrasse 67, 1221 Vienna, Austria, +43‐1‐20100‐4693</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>serum‐free</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>animal‐free</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>emerging pathogen</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>recombinant therapeutic protein</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>biopharmaceutical manufacturing</value></json:item></subject><articleId><json:string>BIOT200800241</json:string></articleId><arkIstex>ark:/67375/WNG-GRH0PWQM-Q</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>article</json:string></originalGenre><abstract>Mammalian cells are the expression system of choice for therapeutic proteins, especially those requiring complex post‐translational modifications. Traditionally, these cells are grown in medium supplemented with serum and other animal‐ or human‐derived components to support viability and productivity. Such proteins are also typically added as excipients and stabilizers in the final drug formulation. However, the transmission of hepatitis B in the 1970s and of hepatitis C and HIV in the 1980s through plasma‐derived factor VIII concentrates had catastrophic consequences for hemophilia patients. Thus, due to regulatory concerns about the inherent potential for transmission of infectious agents as well as the heterogeneity and lack of reliability of the serum supply, a trend has emerged to eliminate the use of plasma‐derived additives in the production and formulation of recombinant protein therapeutics. This practice began with products used in the treatment of hemophilia and is progressively expanding throughout the entire industry. The plasma‐free method of producing recombinant therapeutics is accomplished by the use of both cell culture media and final product formulations that do not contain animal‐ or human‐derived additives. A number of recombinant therapeutic proteins for the treatment of several different diseases have been produced by plasma‐free processes, with the objective of improving safety by eliminating blood‐borne pathogens or by reducing immunogenicity. This review describes the factors that drove the development of plasma‐free protein therapeutics and provides examples of advances in manufacturing that have made possible the removal of human and animal‐derived products from all steps of recombinant protein production.</abstract><qualityIndicators><score>9.976</score><pdfWordCount>8878</pdfWordCount><pdfCharCount>61316</pdfCharCount><pdfVersion>1.3</pdfVersion><pdfPageCount>16</pdfPageCount><pdfPageSize>595.275 x 790.867 pts</pdfPageSize><pdfWordsPerPage>555</pdfWordsPerPage><pdfText>true</pdfText><refBibsNative>true</refBibsNative><abstractWordCount>248</abstractWordCount><abstractCharCount>1764</abstractCharCount><keywordCount>5</keywordCount></qualityIndicators><title>Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells</title><pmid><json:string>19226552</json:string></pmid><genre><json:string>article</json:string></genre><host><title>Biotechnology Journal</title><language><json:string>unknown</json:string></language><doi><json:string>10.1002/(ISSN)1860-7314</json:string></doi><issn><json:string>1860-6768</json:string></issn><eissn><json:string>1860-7314</json:string></eissn><publisherId><json:string>BIOT</json:string></publisherId><volume>4</volume><issue>2</issue><pages><first>186</first><last>201</last><total>16</total></pages><genre><json:string>journal</json:string></genre><subject><json:item><value>Review</value></json:item><json:item><value>Review</value></json:item></subject></host><namedEntities><unitex><date><json:string>2009</json:string><json:string>1992</json:string><json:string>1997</json:string><json:string>1990s</json:string><json:string>1993</json:string><json:string>1998</json:string><json:string>2007</json:string><json:string>1970s</json:string><json:string>2003</json:string><json:string>1984</json:string><json:string>2008</json:string><json:string>1980s</json:string><json:string>2004</json:string><json:string>1996</json:string><json:string>1985</json:string></date><geogName></geogName><orgName><json:string>Organization Recommendation The European Medicines Evaluation Agency</json:string><json:string>EMEA</json:string><json:string>National Hemophilia Foundation</json:string><json:string>US Department of Agriculture</json:string><json:string>UK Health Protection Agency</json:string><json:string>UK, US and France</json:string><json:string>US Centers for Disease Control and Prevention</json:string><json:string>Biotech</json:string><json:string>Japan and the US</json:string><json:string>Broomfield, CO</json:string><json:string>Australia, New Zealand, Denmark, Ireland, Canada and Japan</json:string><json:string>Institute of Applied Microbiology</json:string><json:string>Committee for Proprietary Medicinal Products</json:string><json:string>US, Eprex</json:string><json:string>CBER, Center for Biologics Evaluation and Research</json:string><json:string>University of Applied Life Sciences</json:string><json:string>CDC</json:string><json:string>World Health Organization</json:string></orgName><orgName_funder></orgName_funder><orgName_provider></orgName_provider><persName><json:string>Manfred Reiter</json:string><json:string>Sonia Nasr</json:string><json:string>Sean Brugger</json:string><json:string>Council</json:string><json:string>In</json:string><json:string>Paul Woo</json:string><json:string>Thomas R. Kreil</json:string></persName><placeName><json:string>Nile</json:string><json:string>UK</json:string><json:string>US</json:string><json:string>Austria</json:string><json:string>Europe</json:string><json:string>America</json:string><json:string>Vienna</json:string><json:string>European Union</json:string></placeName><ref_url><json:string>http://www.fda.gov/cber/bse/bse.htm</json:string><json:string>http://www.cdc.gov/mmwr/preview/mmwrhtml/</json:string><json:string>http://www.hpa.org.uk/ infections/topics_az/cjd/vCJDBloodDonors.htm</json:string><json:string>http://www.who</json:string><json:string>http://www.cjd.ed.ac.uk/vcjdworld</json:string></ref_url><ref_bibl><json:string>[83]</json:string><json:string>[4]</json:string><json:string>[79-82]</json:string><json:string>[12]</json:string><json:string>[58, 88]</json:string><json:string>[6]</json:string><json:string>[71]</json:string><json:string>[55]</json:string><json:string>[32, 33]</json:string><json:string>[45, 65-67]</json:string><json:string>[39]</json:string><json:string>[70]</json:string><json:string>[1]</json:string><json:string>[87]</json:string><json:string>[49]</json:string><json:string>[3]</json:string><json:string>[32, 37, 38]</json:string><json:string>[86]</json:string><json:string>[13, 14]</json:string><json:string>[5]</json:string><json:string>[59]</json:string><json:string>[85]</json:string><json:string>[7]</json:string><json:string>[69]</json:string><json:string>[84]</json:string><json:string>[2]</json:string><json:string>[24]</json:string><json:string>[19]</json:string></ref_bibl><bibl></bibl></unitex></namedEntities><ark><json:string>ark:/67375/WNG-GRH0PWQM-Q</json:string></ark><categories><wos><json:string>1 - science</json:string><json:string>2 - biotechnology & applied microbiology</json:string><json:string>2 - biochemical research methods</json:string></wos><scienceMetrix><json:string>1 - applied sciences</json:string><json:string>2 - enabling & strategic technologies</json:string><json:string>3 - biotechnology</json:string></scienceMetrix><scopus><json:string>1 - Life Sciences</json:string><json:string>2 - Biochemistry, Genetics and Molecular Biology</json:string><json:string>3 - Molecular Medicine</json:string><json:string>1 - Life Sciences</json:string><json:string>2 - Immunology and Microbiology</json:string><json:string>3 - Applied Microbiology and Biotechnology</json:string><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - General Medicine</json:string></scopus><inist><json:string>1 - sciences appliquees, technologies et medecines</json:string><json:string>2 - sciences biologiques et medicales</json:string><json:string>3 - sciences medicales</json:string></inist></categories><publicationDate>2009</publicationDate><copyrightDate>2009</copyrightDate><doi><json:string>10.1002/biot.200800241</json:string></doi><id>E40FB9671119F56E8D2E3BE8E8E531FACEEB1163</id><score>1</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/ark:/67375/WNG-GRH0PWQM-Q/fulltext.pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/ark:/67375/WNG-GRH0PWQM-Q/bundle.zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/ark:/67375/WNG-GRH0PWQM-Q/fulltext.tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main">Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>WILEY‐VCH Verlag</publisher><pubPlace>Weinheim</pubPlace><availability><licence>Copyright © 2009 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim</licence></availability><date type="published" when="2009-02"></date></publicationStmt><notesStmt><note type="content-type" subtype="article" source="article" scheme="https://content-type.data.istex.fr/ark:/67375/XTP-6N5SZHKN-D">article</note><note type="publication-type" subtype="journal" scheme="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</note></notesStmt><sourceDesc><biblStruct type="article"><analytic><title level="a" type="main">Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells</title><author xml:id="author-0000"><persName><forename type="first">Leopold</forename><surname>Grillberger</surname></persName><affiliation><address><addrLine>Baxter BioScience</addrLine><addrLine>Vienna, Austria</addrLine><country key="AT" xml:lang="en">AUSTRIA</country></address></affiliation></author><author xml:id="author-0001"><persName><forename type="first">Thomas R.</forename><surname>Kreil</surname></persName><affiliation><address><addrLine>Baxter BioScience</addrLine><addrLine>Vienna, Austria</addrLine><country key="AT" xml:lang="en">AUSTRIA</country></address></affiliation></author><author xml:id="author-0002"><persName><forename type="first">Sonia</forename><surname>Nasr</surname></persName><affiliation><address><addrLine>Therapy Management Specialists</addrLine><addrLine>Inc., Broomfield, CO, USA</addrLine><country key="AT" xml:lang="en">AUSTRIA</country></address></affiliation></author><author xml:id="author-0003" role="corresp"><persName><forename type="first">Manfred</forename><surname>Reiter</surname></persName><email>manfred_reiter@baxter.com</email><affiliation><address><addrLine>Baxter BioScience</addrLine><addrLine>Vienna, Austria</addrLine><country key="AT" xml:lang="en">AUSTRIA</country></address></affiliation></author><idno type="istex">E40FB9671119F56E8D2E3BE8E8E531FACEEB1163</idno><idno type="ark">ark:/67375/WNG-GRH0PWQM-Q</idno><idno type="DOI">10.1002/biot.200800241</idno><idno type="unit">BIOT200800241</idno><idno type="toTypesetVersion">file:BIOT.BIOT200800241.pdf</idno></analytic><monogr><title level="j" type="main">Biotechnology Journal</title><title level="j" type="sub">Cell and Protein Manipulation</title><title level="j" type="alt">BIOTECHNOLOGY JOURNAL</title><idno type="pISSN">1860-6768</idno><idno type="eISSN">1860-7314</idno><idno type="book-DOI">10.1002/(ISSN)1860-7314</idno><idno type="book-part-DOI">10.1002/biot.v4:2</idno><idno type="product">BIOT</idno><imprint><biblScope unit="vol">4</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="186">186</biblScope><biblScope unit="page" to="201">201</biblScope><biblScope unit="page-count">16</biblScope><publisher>WILEY‐VCH Verlag</publisher><pubPlace>Weinheim</pubPlace><date type="published" when="2009-02"></date></imprint></monogr></biblStruct></sourceDesc></fileDesc><encodingDesc><schemaRef type="ODD" url="https://xml-schema.delivery.istex.fr/tei-istex.odd"></schemaRef><appInfo><application ident="pub2tei" version="1.0.10" when="2019-12-20"><label>pub2TEI-ISTEX</label><desc>A set of style sheets for converting XML documents encoded in various scientific publisher formats into a common TEI format.
<ref target="http://www.tei-c.org/">We use TEI</ref></desc></application></appInfo></encodingDesc><profileDesc><abstract xml:lang="en" style="main"><head>Abstract</head><p>Mammalian cells are the expression system of choice for therapeutic proteins, especially those requiring complex post‐translational modifications. Traditionally, these cells are grown in medium supplemented with serum and other animal‐ or human‐derived components to support viability and productivity. Such proteins are also typically added as excipients and stabilizers in the final drug formulation. However, the transmission of hepatitis B in the 1970s and of hepatitis C and HIV in the 1980s through plasma‐derived factor VIII concentrates had catastrophic consequences for hemophilia patients. Thus, due to regulatory concerns about the inherent potential for transmission of infectious agents as well as the heterogeneity and lack of reliability of the serum supply, a trend has emerged to eliminate the use of plasma‐derived additives in the production and formulation of recombinant protein therapeutics. This practice began with products used in the treatment of hemophilia and is progressively expanding throughout the entire industry. The plasma‐free method of producing recombinant therapeutics is accomplished by the use of both cell culture media and final product formulations that do not contain animal‐ or human‐derived additives. A number of recombinant therapeutic proteins for the treatment of several different diseases have been produced by plasma‐free processes, with the objective of improving safety by eliminating blood‐borne pathogens or by reducing immunogenicity. This review describes the factors that drove the development of plasma‐free protein therapeutics and provides examples of advances in manufacturing that have made possible the removal of human and animal‐derived products from all steps of recombinant protein production.</p></abstract><textClass><keywords xml:lang="en"><term xml:id="kwd1">serum‐free</term><term xml:id="kwd2">animal‐free</term><term xml:id="kwd3">emerging pathogen</term><term xml:id="kwd4">recombinant therapeutic protein</term><term xml:id="kwd5">biopharmaceutical manufacturing</term></keywords><keywords rend="articleCategory"><term>Review</term></keywords><keywords rend="tocHeading1"><term>Review</term></keywords></textClass><langUsage><language ident="en"></language></langUsage></profileDesc><revisionDesc><change when="2019-12-20" who="#istex" xml:id="pub2tei">formatting</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/ark:/67375/WNG-GRH0PWQM-Q/fulltext.txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>WILEY‐VCH Verlag</publisherName><publisherLoc>Weinheim</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1860-7314</doi><issn type="print">1860-6768</issn><issn type="electronic">1860-7314</issn><idGroup><id type="product" value="BIOT"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="BIOTECHNOLOGY JOURNAL">Biotechnology Journal</title><title type="short">Biotechnology Journal</title></titleGroup></publicationMeta><publicationMeta level="part" position="20"><doi origin="wiley" registered="yes">10.1002/biot.v4:2</doi><titleGroup><title type="specialIssueTitle">Cell and Protein Manipulation</title></titleGroup><numberingGroup><numbering type="journalVolume" number="4">4</numbering><numbering type="journalIssue">2</numbering></numberingGroup><coverDate startDate="2009-02">February 2009</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="14" status="forIssue"><doi origin="wiley" registered="yes">10.1002/biot.200800241</doi><idGroup><id type="unit" value="BIOT200800241"></id></idGroup><countGroup><count type="pageTotal" number="16"></count></countGroup><titleGroup><title type="articleCategory">Review</title><title type="tocHeading1">Review</title></titleGroup><copyright ownership="publisher">Copyright © 2009 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim</copyright><eventGroup><event type="manuscriptReceived" date="2008-09-30"></event><event type="manuscriptRevised" date="2008-12-03"></event><event type="manuscriptAccepted" date="2008-12-05"></event><event type="firstOnline" date="2009-02-18"></event><event type="publishedOnlineFinalForm" date="2009-02-18"></event><event type="xmlConverted" agent="Converter:JWSART34_TO_WML3G version:2.3.19 mode:FullText" date="2010-09-16"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-01-07"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-10-15"></event></eventGroup><numberingGroup><numbering type="pageFirst">186</numbering><numbering type="pageLast">201</numbering></numberingGroup><correspondenceTo>R & D Upstream Process Development, Baxter Innovations GmbH, Industriestrasse 67, 1221 Vienna, Austria, <b>Fax:</b> +43‐1‐20100‐4693</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:BIOT.BIOT200800241.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="4"></count><count type="tableTotal" number="3"></count><count type="referenceTotal" number="88"></count></countGroup><titleGroup><title type="main" xml:lang="en">Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#a1"><personName><givenNames>Leopold</givenNames><familyName>Grillberger</familyName></personName></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#a1"><personName><givenNames>Thomas R.</givenNames><familyName>Kreil</familyName></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#a2"><personName><givenNames>Sonia</givenNames><familyName>Nasr</familyName></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#a1" corresponding="yes"><personName><givenNames>Manfred</givenNames><familyName>Reiter</familyName></personName><contactDetails><email>manfred_reiter@baxter.com</email></contactDetails></creator></creators><affiliationGroup><affiliation xml:id="a1" countryCode="AT" type="organization"><unparsedAffiliation>Baxter BioScience, Vienna, Austria</unparsedAffiliation></affiliation><affiliation xml:id="a2" countryCode="AT" type="organization"><unparsedAffiliation>Therapy Management Specialists, Inc., Broomfield, CO, USA</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">serum‐free</keyword><keyword xml:id="kwd2">animal‐free</keyword><keyword xml:id="kwd3">emerging pathogen</keyword><keyword xml:id="kwd4">recombinant therapeutic protein</keyword><keyword xml:id="kwd5">biopharmaceutical manufacturing</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Mammalian cells are the expression system of choice for therapeutic proteins, especially those requiring complex post‐translational modifications. Traditionally, these cells are grown in medium supplemented with serum and other animal‐ or human‐derived components to support viability and productivity. Such proteins are also typically added as excipients and stabilizers in the final drug formulation. However, the transmission of hepatitis B in the 1970s and of hepatitis C and HIV in the 1980s through plasma‐derived factor VIII concentrates had catastrophic consequences for hemophilia patients. Thus, due to regulatory concerns about the inherent potential for transmission of infectious agents as well as the heterogeneity and lack of reliability of the serum supply, a trend has emerged to eliminate the use of plasma‐derived additives in the production and formulation of recombinant protein therapeutics. This practice began with products used in the treatment of hemophilia and is progressively expanding throughout the entire industry. The plasma‐free method of producing recombinant therapeutics is accomplished by the use of both cell culture media and final product formulations that do not contain animal‐ or human‐derived additives. A number of recombinant therapeutic proteins for the treatment of several different diseases have been produced by plasma‐free processes, with the objective of improving safety by eliminating blood‐borne pathogens or by reducing immunogenicity. This review describes the factors that drove the development of plasma‐free protein therapeutics and provides examples of advances in manufacturing that have made possible the removal of human and animal‐derived products from all steps of recombinant protein production.</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells</title></titleInfo><name type="personal"><namePart type="given">Leopold</namePart><namePart type="family">Grillberger</namePart><affiliation>Baxter BioScience, Vienna, Austria</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Thomas R.</namePart><namePart type="family">Kreil</namePart><affiliation>Baxter BioScience, Vienna, Austria</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Sonia</namePart><namePart type="family">Nasr</namePart><affiliation>Therapy Management Specialists, Inc., Broomfield, CO, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Manfred</namePart><namePart type="family">Reiter</namePart><affiliation>Baxter BioScience, Vienna, Austria</affiliation><affiliation>E-mail: manfred_reiter@baxter.com</affiliation><affiliation>Correspondence address: R & D Upstream Process Development, Baxter Innovations GmbH, Industriestrasse 67, 1221 Vienna, Austria, +43‐1‐20100‐4693</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-6N5SZHKN-D">article</genre><originInfo><publisher>WILEY‐VCH Verlag</publisher><place><placeTerm type="text">Weinheim</placeTerm></place><dateIssued encoding="w3cdtf">2009-02</dateIssued><dateCaptured encoding="w3cdtf">2008-09-30</dateCaptured><dateValid encoding="w3cdtf">2008-12-05</dateValid><copyrightDate encoding="w3cdtf">2009</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><extent unit="figures">4</extent><extent unit="tables">3</extent><extent unit="references">88</extent></physicalDescription><abstract lang="en">Mammalian cells are the expression system of choice for therapeutic proteins, especially those requiring complex post‐translational modifications. Traditionally, these cells are grown in medium supplemented with serum and other animal‐ or human‐derived components to support viability and productivity. Such proteins are also typically added as excipients and stabilizers in the final drug formulation. However, the transmission of hepatitis B in the 1970s and of hepatitis C and HIV in the 1980s through plasma‐derived factor VIII concentrates had catastrophic consequences for hemophilia patients. Thus, due to regulatory concerns about the inherent potential for transmission of infectious agents as well as the heterogeneity and lack of reliability of the serum supply, a trend has emerged to eliminate the use of plasma‐derived additives in the production and formulation of recombinant protein therapeutics. This practice began with products used in the treatment of hemophilia and is progressively expanding throughout the entire industry. The plasma‐free method of producing recombinant therapeutics is accomplished by the use of both cell culture media and final product formulations that do not contain animal‐ or human‐derived additives. A number of recombinant therapeutic proteins for the treatment of several different diseases have been produced by plasma‐free processes, with the objective of improving safety by eliminating blood‐borne pathogens or by reducing immunogenicity. This review describes the factors that drove the development of plasma‐free protein therapeutics and provides examples of advances in manufacturing that have made possible the removal of human and animal‐derived products from all steps of recombinant protein production.</abstract><subject lang="en"><genre>keywords</genre><topic>serum‐free</topic><topic>animal‐free</topic><topic>emerging pathogen</topic><topic>recombinant therapeutic protein</topic><topic>biopharmaceutical manufacturing</topic></subject><relatedItem type="host"><titleInfo><title>Biotechnology Journal</title></titleInfo><titleInfo type="abbreviated"><title>Biotechnology Journal</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><subject><genre>article-category</genre><topic>Review</topic><topic>Review</topic></subject><identifier type="ISSN">1860-6768</identifier><identifier type="eISSN">1860-7314</identifier><identifier type="DOI">10.1002/(ISSN)1860-7314</identifier><identifier type="PublisherID">BIOT</identifier><part><date>2009</date><detail type="title"><title>Cell and Protein Manipulation</title></detail><detail type="volume"><caption>vol.</caption><number>4</number></detail><detail type="issue"><caption>no.</caption><number>2</number></detail><extent unit="pages"><start>186</start><end>201</end><total>16</total></extent></part></relatedItem><relatedItem type="references" displayLabel="cit1"><titleInfo><title>Biopharmaceutical benchmarks.</title></titleInfo><name type="personal"><namePart type="given">G.</namePart><namePart type="family">Walsh</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Walsh, G., Biopharmaceutical benchmarks. Nature Biotech. 2006, 24, 769–776.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>24</number></detail><extent unit="pages"><start>769</start><end>776</end></extent></part><relatedItem type="host"><titleInfo><title>Nature Biotech.</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>24</number></detail><extent unit="pages"><start>769</start><end>776</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit2"><titleInfo><title>Recombinant therapeutic proteins: production platforms and challenges.</title></titleInfo><name type="personal"><namePart type="given">T.</namePart><namePart type="family">Dingermann</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Dingermann, T., Recombinant therapeutic proteins: production platforms and challenges. Biotechnol J. 2008, 3, 90–97.</note><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>3</number></detail><extent unit="pages"><start>90</start><end>97</end></extent></part><relatedItem type="host"><titleInfo><title>Biotechnol J.</title></titleInfo><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>3</number></detail><extent unit="pages"><start>90</start><end>97</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit3"><titleInfo><title>Production of recombinant protein therapeutics in cultivated mammalian cells.</title></titleInfo><name type="personal"><namePart type="given">F. M.</namePart><namePart type="family">Wurm</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Wurm, F. M., Production of recombinant protein therapeutics in cultivated mammalian cells. Nature Biotech. 2004, 22, 1393–1398.</note><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>22</number></detail><extent unit="pages"><start>1393</start><end>1398</end></extent></part><relatedItem type="host"><titleInfo><title>Nature Biotech.</title></titleInfo><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>22</number></detail><extent unit="pages"><start>1393</start><end>1398</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit4"><titleInfo><title>Assessment of cell engineering strategies for improved therapeutic protein production in CHO cells.</title></titleInfo><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Mohan</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Y. G.</namePart><namePart type="family">Kim</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Koo</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G. M.</namePart><namePart type="family">Lee</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Mohan, C., Kim, Y. G., Koo, J., Lee, G. M., Assessment of cell engineering strategies for improved therapeutic protein production in CHO cells. Biotechnol J. 2008, 3, 624–630.</note><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>3</number></detail><extent unit="pages"><start>624</start><end>630</end></extent></part><relatedItem type="host"><titleInfo><title>Biotechnol J.</title></titleInfo><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>3</number></detail><extent unit="pages"><start>624</start><end>630</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit5"><titleInfo><title>Advances in the production of human therapeutic proteins in yeasts and filamentous fungi.</title></titleInfo><name type="personal"><namePart type="given">T.U.</namePart><namePart type="family">Gerngross</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Gerngross, T.U., Advances in the production of human therapeutic proteins in yeasts and filamentous fungi. Nature Biotech. 2004, 22, 1409–1414.</note><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>22</number></detail><extent unit="pages"><start>1409</start><end>1414</end></extent></part><relatedItem type="host"><titleInfo><title>Nature Biotech.</title></titleInfo><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>22</number></detail><extent unit="pages"><start>1409</start><end>1414</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit6"><titleInfo><title>Anti‐hemophilic factor (recombinant), plasma/albumin‐free method (octocog‐alpha; ADVATE) in the management of hemophilia A.</title></titleInfo><name type="personal"><namePart type="given">A. D.</namePart><namePart type="family">Shapiro</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Shapiro, A. D., Anti‐hemophilic factor (recombinant), plasma/albumin‐free method (octocog‐alpha; ADVATE) in the management of hemophilia A. Vasc Health Risk Manag. 2007, 3, 555–565.</note><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>3</number></detail><extent unit="pages"><start>555</start><end>565</end></extent></part><relatedItem type="host"><titleInfo><title>Vasc Health Risk Manag.</title></titleInfo><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>3</number></detail><extent unit="pages"><start>555</start><end>565</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit7"><titleInfo><title>Hemophilia therapy innovation: development of an advanced category recombinant factor VIII by a plasma/albumin‐free method. Proceedings of a Special Symposium at the XIXth Congress of the International Society on Thrombosis and Haemostasis, July 12–18, 2003, Birmingham, UK.</title></titleInfo><name type="personal"><namePart type="given">B. M.</namePart><namePart type="family">Ewenstein</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.</namePart><namePart type="family">Collins</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M. D.</namePart><namePart type="family">Tarantino</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Negrier</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Ewenstein, B. M., Collins, P., Tarantino, M. D., Negrier, C. et al., Hemophilia therapy innovation: development of an advanced category recombinant factor VIII by a plasma/albumin‐free method. Proceedings of a Special Symposium at the XIXth Congress of the International Society on Thrombosis and Haemostasis, July 12–18, 2003, Birmingham, UK. Semin Hematol. 2004, 41, 1 2 (Suppl ), 1–16.</note><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>41</number></detail><detail type="issue"><caption>no.</caption><number>1 2</number></detail><extent unit="pages"><start>1</start><end>16</end></extent></part><relatedItem type="host"><titleInfo><title>Semin Hematol.</title></titleInfo><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>41</number></detail><detail type="issue"><caption>no.</caption><number>1 2</number></detail><extent unit="pages"><start>1</start><end>16</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit8"><titleInfo><title>Emerging infectious threats to the blood supply.</title></titleInfo><name type="personal"><namePart type="given">R. Y.</namePart><namePart type="family">Dodd</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D. A.</namePart><namePart type="family">Leiby</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Dodd, R. Y., Leiby, D. A., Emerging infectious threats to the blood supply. Annu Rev Med. 2004, 55, 191–207.</note><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>55</number></detail><extent unit="pages"><start>191</start><end>207</end></extent></part><relatedItem type="host"><titleInfo><title>Annu Rev Med.</title></titleInfo><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>55</number></detail><extent unit="pages"><start>191</start><end>207</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit9"><titleInfo><title>Isolation and characterization of viruses related to the SARS coronavirus from animals in southern China.</title></titleInfo><name type="personal"><namePart type="given">Y.</namePart><namePart type="family">Guan</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B. J.</namePart><namePart type="family">Zheng</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Y. Q.</namePart><namePart type="family">He</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">X. L.</namePart><namePart type="family">Liu</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Guan, Y., Zheng, B. J., He, Y. Q., Liu, X. L. et al., Isolation and characterization of viruses related to the SARS coronavirus from animals in southern China. Science 2003, 302, 276–278.</note><part><date>2003</date><detail type="volume"><caption>vol.</caption><number>302</number></detail><extent unit="pages"><start>276</start><end>278</end></extent></part><relatedItem type="host"><titleInfo><title>Science</title></titleInfo><part><date>2003</date><detail type="volume"><caption>vol.</caption><number>302</number></detail><extent unit="pages"><start>276</start><end>278</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit10"><titleInfo><title>TTV, a new human virus with single stranded circular DNA genome.</title></titleInfo><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Hino</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Hino, S., TTV, a new human virus with single stranded circular DNA genome. Rev Med Virol. 2002, 12, 151–158.</note><part><date>2002</date><detail type="volume"><caption>vol.</caption><number>12</number></detail><extent unit="pages"><start>151</start><end>158</end></extent></part><relatedItem type="host"><titleInfo><title>Rev Med Virol.</title></titleInfo><part><date>2002</date><detail type="volume"><caption>vol.</caption><number>12</number></detail><extent unit="pages"><start>151</start><end>158</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit11"><titleInfo><title>The need for recombinant factor VIII: historical background and rationale.</title></titleInfo><name type="personal"><namePart type="given">M.W.</namePart><namePart type="family">Hilgartner</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Hilgartner, M.W., The need for recombinant factor VIII: historical background and rationale. Semin Hematol. 1991, 28, (2 Suppl 1), 6–9.</note><part><date>1991</date><detail type="volume"><caption>vol.</caption><number>28</number></detail><detail type="issue"><caption>no.</caption><number>2 Suppl 1</number></detail><extent unit="pages"><start>6</start><end>9</end></extent></part><relatedItem type="host"><titleInfo><title>Semin Hematol.</title></titleInfo><part><date>1991</date><detail type="volume"><caption>vol.</caption><number>28</number></detail><detail type="issue"><caption>no.</caption><number>2 Suppl 1</number></detail><extent unit="pages"><start>6</start><end>9</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit12"><titleInfo><title>Clinical perspectives of emerging pathogens in bleeding disorders.</title></titleInfo><name type="personal"><namePart type="given">C. A.</namePart><namePart type="family">Ludlam</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">W. G.</namePart><namePart type="family">Powderly</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Bozzette</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Diamond</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Ludlam, C. A., Powderly, W. G., Bozzette, S., Diamond, M. et al., Clinical perspectives of emerging pathogens in bleeding disorders. Lancet 2006, 367, 252–261.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>367</number></detail><extent unit="pages"><start>252</start><end>261</end></extent></part><relatedItem type="host"><titleInfo><title>Lancet</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>367</number></detail><extent unit="pages"><start>252</start><end>261</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit13"><titleInfo><title>Frequency of contamination of coagulation factor concentrates with novel human parvovirus PARV4</title></titleInfo><name type="personal"><namePart type="given">B.</namePart><namePart type="family">Schneider</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. F.</namePart><namePart type="family">Fryer</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Oldenburg</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H. H.</namePart><namePart type="family">Brackmann</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Schneider, B., Fryer, J. F., Oldenburg, J., Brackmann, H. H. et al., Frequency of contamination of coagulation factor concentrates with novel human parvovirus PARV4. Haemophilia 2008, Jun 18.</note><part><date>2008</date></part><relatedItem type="host"><titleInfo><title>Haemophilia</title></titleInfo><part><date>2008</date></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit14"><titleInfo><title>Human parvovirus PARV4 in clotting factor VIII concentrates.</title></titleInfo><name type="personal"><namePart type="given">J. F.</namePart><namePart type="family">Fryer</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A. R.</namePart><namePart type="family">Hubbard</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S. A.</namePart><namePart type="family">Baylis</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Fryer, J. F., Hubbard, A. R., Baylis, S. A., Human parvovirus PARV4 in clotting factor VIII concentrates. Vox Sang. 2007, 93, 341–347.</note><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>93</number></detail><extent unit="pages"><start>341</start><end>347</end></extent></part><relatedItem type="host"><titleInfo><title>Vox Sang.</title></titleInfo><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>93</number></detail><extent unit="pages"><start>341</start><end>347</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit15"><titleInfo><title>Human parvovirus B19 in young male patients with hemophilia A: associations with treatment product exposure and joint range‐of‐motion limitation.</title></titleInfo><name type="personal"><namePart type="given">J. M.</namePart><namePart type="family">Soucie</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">E.B.</namePart><namePart type="family">Siwak</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">W.C.</namePart><namePart type="family">Hooper</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B. L.</namePart><namePart type="family">Evatt</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Soucie, J. M., Siwak, E.B., Hooper, W.C., Evatt, B. L. et al., Human parvovirus B19 in young male patients with hemophilia A: associations with treatment product exposure and joint range‐of‐motion limitation. Transfusion 2004, 44, 1179–1185.</note><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>44</number></detail><extent unit="pages"><start>1179</start><end>1185</end></extent></part><relatedItem type="host"><titleInfo><title>Transfusion</title></titleInfo><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>44</number></detail><extent unit="pages"><start>1179</start><end>1185</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit16"><titleInfo><title>Suivi Thérapeutique National des Hémophiles Group. Prevalence of IgG antibodies to human parvovirus B19 in haemophilia children treated with recombinant factor (F)VIII only or with at least one plasma‐derived FVIII or FIX concentrate: results from the French haemophilia cohort.</title></titleInfo><name type="personal"><namePart type="given">V.</namePart><namePart type="family">Gaboulaud</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Parquet</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Tahiri</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Claeyssens</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Gaboulaud, V., Parquet, A., Tahiri, C., Claeyssens, S. et al., Suivi Thérapeutique National des Hémophiles Group. Prevalence of IgG antibodies to human parvovirus B19 in haemophilia children treated with recombinant factor (F)VIII only or with at least one plasma‐derived FVIII or FIX concentrate: results from the French haemophilia cohort. Br J Haematol. 2002, 116, 383–389.</note><part><date>2002</date><detail type="volume"><caption>vol.</caption><number>116</number></detail><extent unit="pages"><start>383</start><end>389</end></extent></part><relatedItem type="host"><titleInfo><title>Br J Haematol.</title></titleInfo><part><date>2002</date><detail type="volume"><caption>vol.</caption><number>116</number></detail><extent unit="pages"><start>383</start><end>389</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit17"><titleInfo><title>Molecular cloning of a cDNA encoding human antihaemophilic factor. 1984.</title></titleInfo><name type="personal"><namePart type="given">J. J.</namePart><namePart type="family">Toole</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. L.</namePart><namePart type="family">Knopf</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. M.</namePart><namePart type="family">Wozney</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">L. A.</namePart><namePart type="family">Sultzman</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Toole, J. J., Knopf, J. L., Wozney, J. M., Sultzman, L. A. et al., Molecular cloning of a cDNA encoding human antihaemophilic factor. 1984. Biotechnology 1992, 24, 310–315.</note><part><date>1992</date><detail type="volume"><caption>vol.</caption><number>24</number></detail><extent unit="pages"><start>310</start><end>315</end></extent></part><relatedItem type="host"><titleInfo><title>Biotechnology</title></titleInfo><part><date>1992</date><detail type="volume"><caption>vol.</caption><number>24</number></detail><extent unit="pages"><start>310</start><end>315</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit18"><titleInfo><title>Structure of human factor VIII.</title></titleInfo><name type="personal"><namePart type="given">G. A.</namePart><namePart type="family">Vehar</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B.</namePart><namePart type="family">Keyt</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Eaton</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Rodriguez</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Vehar, G. A., Keyt, B., Eaton, D., Rodriguez, H. et al., Structure of human factor VIII. Nature 1984, 312, 337–342.</note><part><date>1984</date><detail type="volume"><caption>vol.</caption><number>312</number></detail><extent unit="pages"><start>337</start><end>342</end></extent></part><relatedItem type="host"><titleInfo><title>Nature</title></titleInfo><part><date>1984</date><detail type="volume"><caption>vol.</caption><number>312</number></detail><extent unit="pages"><start>337</start><end>342</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit19"><titleInfo><title>A multicenter pharmacosurveillance study for the evaluation of the efficacy and safety of recombinant factor VIII in the treatment of patients with hemophilia A. German Kogenate Study Group.</title></titleInfo><name type="personal"><namePart type="given">E.</namePart><namePart type="family">Aygoren‐Pursun</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">I.</namePart><namePart type="family">Scharrer</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Aygoren‐Pursun, E., Scharrer, I., A multicenter pharmacosurveillance study for the evaluation of the efficacy and safety of recombinant factor VIII in the treatment of patients with hemophilia A. German Kogenate Study Group. Thromb Haemost. 1997, 78, 1352–1356.</note><part><date>1997</date><detail type="volume"><caption>vol.</caption><number>78</number></detail><extent unit="pages"><start>1352</start><end>1356</end></extent></part><relatedItem type="host"><titleInfo><title>Thromb Haemost.</title></titleInfo><part><date>1997</date><detail type="volume"><caption>vol.</caption><number>78</number></detail><extent unit="pages"><start>1352</start><end>1356</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit20"><titleInfo><title>rAHF‐PFM Clinical Study Group. Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin‐free method: pharmacokinetics, efficacy, and safety in previously treated patients with haemophilia A.</title></titleInfo><name type="personal"><namePart type="given">M.D.</namePart><namePart type="family">Tarantino</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.W.</namePart><namePart type="family">Collins</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C. R.</namePart><namePart type="family">Hay</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.D.</namePart><namePart type="family">Shapiro</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Tarantino, M.D., Collins, P.W., Hay, C. R., Shapiro, A.D. et al., rAHF‐PFM Clinical Study Group. Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin‐free method: pharmacokinetics, efficacy, and safety in previously treated patients with haemophilia A. Haemophilia 2004, 10, 428–437.</note><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>10</number></detail><extent unit="pages"><start>428</start><end>437</end></extent></part><relatedItem type="host"><titleInfo><title>Haemophilia</title></titleInfo><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>10</number></detail><extent unit="pages"><start>428</start><end>437</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit21"><titleInfo><title>Possible transmission of human herpesvirus‐8 by blood transfusion in a historical United States cohort</title></titleInfo><name type="personal"><namePart type="given">S. C.</namePart><namePart type="family">Dollard</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">K. E.</namePart><namePart type="family">Nelson</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P. M.</namePart><namePart type="family">Ness</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">V.</namePart><namePart type="family">Stambolis</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Dollard, S. C., Nelson, K. E., Ness, P. M., Stambolis, V. et al., Possible transmission of human herpesvirus‐8 by blood transfusion in a historical United States cohort. Transfusion 2005, 45, 500–503.</note><part><date>2005</date><detail type="volume"><caption>vol.</caption><number>45</number></detail><extent unit="pages"><start>500</start><end>503</end></extent></part><relatedItem type="host"><titleInfo><title>Transfusion</title></titleInfo><part><date>2005</date><detail type="volume"><caption>vol.</caption><number>45</number></detail><extent unit="pages"><start>500</start><end>503</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit22"><titleInfo><title>Transmission of human herpesvirus 8 by blood transfusion.</title></titleInfo><name type="personal"><namePart type="given">W.</namePart><namePart type="family">Hladik</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S. C.</namePart><namePart type="family">Dollard</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Mermin</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A. L.</namePart><namePart type="family">Fowlkes</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Hladik, W., Dollard, S. C., Mermin, J., Fowlkes, A. L. et al., Transmission of human herpesvirus 8 by blood transfusion. Engl J Med. 2006, 355, 1331–1338.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>355</number></detail><extent unit="pages"><start>1331</start><end>1338</end></extent></part><relatedItem type="host"><titleInfo><title>Engl J Med.</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>355</number></detail><extent unit="pages"><start>1331</start><end>1338</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit23"><titleInfo><title>Emerging issues in blood safety.</title></titleInfo><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Chamberland</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R. F.</namePart><namePart type="family">Khabbaz</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Chamberland, M., Khabbaz, R. F., Emerging issues in blood safety. Infect Dis Clin North Am. 1998, 12, 217–229.</note><part><date>1998</date><detail type="volume"><caption>vol.</caption><number>12</number></detail><extent unit="pages"><start>217</start><end>229</end></extent></part><relatedItem type="host"><titleInfo><title>Infect Dis Clin North Am.</title></titleInfo><part><date>1998</date><detail type="volume"><caption>vol.</caption><number>12</number></detail><extent unit="pages"><start>217</start><end>229</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit24"><titleInfo><title>Emerging infectious disease issues in blood safety.</title></titleInfo><name type="personal"><namePart type="given">M. E.</namePart><namePart type="family">Chamberland</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H. J.</namePart><namePart type="family">Alter</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M. P.</namePart><namePart type="family">Busch</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G.</namePart><namePart type="family">Nemo</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Chamberland, M. E., Alter, H. J., Busch, M. P., Nemo, G. et al., Emerging infectious disease issues in blood safety. Emerg. Infect. Dis. 2001, 7, 552–553.</note><part><date>2001</date><detail type="volume"><caption>vol.</caption><number>7</number></detail><extent unit="pages"><start>552</start><end>553</end></extent></part><relatedItem type="host"><titleInfo><title>Emerg. Infect. Dis.</title></titleInfo><part><date>2001</date><detail type="volume"><caption>vol.</caption><number>7</number></detail><extent unit="pages"><start>552</start><end>553</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit25"><titleInfo><title>Diagnosis of new variant Creutzfeldt‐Jakob disease by tonsil biopsy.</title></titleInfo><name type="personal"><namePart type="given">A. F.</namePart><namePart type="family">Hill</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Zeidler</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Ironside</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Collinge</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Hill, A. F., Zeidler, M., Ironside, J., Collinge, J., Diagnosis of new variant Creutzfeldt‐Jakob disease by tonsil biopsy. Lancet 1997, 349, 99–100.</note><part><date>1997</date><detail type="volume"><caption>vol.</caption><number>349</number></detail><extent unit="pages"><start>99</start><end>100</end></extent></part><relatedItem type="host"><titleInfo><title>Lancet</title></titleInfo><part><date>1997</date><detail type="volume"><caption>vol.</caption><number>349</number></detail><extent unit="pages"><start>99</start><end>100</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit26"><titleInfo><title>Possible transmission of variant Creutzfeldt‐Jakob disease by blood transfusion.</title></titleInfo><name type="personal"><namePart type="given">C. A.</namePart><namePart type="family">Llewelyn</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P. E.</namePart><namePart type="family">Hewitt</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R. S. G.</namePart><namePart type="family">Knight</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">K.</namePart><namePart type="family">Amar</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Llewelyn, C. A., Hewitt, P. E., Knight, R. S. G., Amar, K. et al., Possible transmission of variant Creutzfeldt‐Jakob disease by blood transfusion. Lancet 2004, 363, 417–421.</note><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>363</number></detail><extent unit="pages"><start>417</start><end>421</end></extent></part><relatedItem type="host"><titleInfo><title>Lancet</title></titleInfo><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>363</number></detail><extent unit="pages"><start>417</start><end>421</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit27"><titleInfo><title>Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient.</title></titleInfo><name type="personal"><namePart type="given">A. H.</namePart><namePart type="family">Peden</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.W.</namePart><namePart type="family">Head</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D. L.</namePart><namePart type="family">Ritchie</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. E.</namePart><namePart type="family">Bell</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Peden, A. H., Head, M.W., Ritchie, D. L., Bell, J. E. et al., Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet 2004, 364, 527–529.</note><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>364</number></detail><extent unit="pages"><start>527</start><end>529</end></extent></part><relatedItem type="host"><titleInfo><title>Lancet</title></titleInfo><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>364</number></detail><extent unit="pages"><start>527</start><end>529</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit28"><titleInfo><title>Variant Creutzfeldt‐Jakob disease: risk of transmission by blood and blood products.</title></titleInfo><name type="personal"><namePart type="given">J.W.</namePart><namePart type="family">Ironside</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.W.</namePart><namePart type="family">Head</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Ironside, J.W., Head, M.W., Variant Creutzfeldt‐Jakob disease: risk of transmission by blood and blood products. Haemophilia 2004, 10, (Suppl 4), 64–69.</note><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>10</number></detail><detail type="issue"><caption>no.</caption><number>Suppl 4</number></detail><extent unit="pages"><start>64</start><end>69</end></extent></part><relatedItem type="host"><titleInfo><title>Haemophilia</title></titleInfo><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>10</number></detail><detail type="issue"><caption>no.</caption><number>Suppl 4</number></detail><extent unit="pages"><start>64</start><end>69</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit29"><titleInfo><title>Prion diseases are efficiently transmitted by blood transfusion in sheep.</title></titleInfo><name type="personal"><namePart type="given">F.</namePart><namePart type="family">Houston</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.</namePart><namePart type="family">McCutcheon</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">W.</namePart><namePart type="family">Goldmann</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Chong</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Houston, F., McCutcheon, S., Goldmann, W., Chong, A. et al., Prion diseases are efficiently transmitted by blood transfusion in sheep. Blood 2008, Jul 22.</note><part><date>2008</date></part><relatedItem type="host"><titleInfo><title>Blood</title></titleInfo><part><date>2008</date></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit30"><titleInfo><title>Managing the risk of transmission of variant Creutzfeldt Jakob disease by blood products.</title></titleInfo><name type="personal"><namePart type="given">C. A.</namePart><namePart type="family">Ludlam</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M. L.</namePart><namePart type="family">Turner</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Ludlam, C. A., Turner, M. L., Managing the risk of transmission of variant Creutzfeldt Jakob disease by blood products. Br J Haematol. 2006, 132, 13–24.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>132</number></detail><extent unit="pages"><start>13</start><end>24</end></extent></part><relatedItem type="host"><titleInfo><title>Br J Haematol.</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>132</number></detail><extent unit="pages"><start>13</start><end>24</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit31"><titleInfo><title>Kuru in the 21st century – an acquired human prion disease with very long incubation periods.</title></titleInfo><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Collinge</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Whitfield</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">E.</namePart><namePart type="family">McKintosh</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Beck</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Collinge, J., Whitfield, J., McKintosh, E., Beck, J. et al., Kuru in the 21st century – an acquired human prion disease with very long incubation periods. Lancet 2006, 367, 2068–2074.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>367</number></detail><extent unit="pages"><start>2068</start><end>2074</end></extent></part><relatedItem type="host"><titleInfo><title>Lancet</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>367</number></detail><extent unit="pages"><start>2068</start><end>2074</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit32"><titleInfo><title>Creutzfeldt‐Jakob disease in a recipient of human pituitary‐derived gonadotrophin: a second case</title></titleInfo><name type="personal"><namePart type="given">J. I.</namePart><namePart type="family">Cochius</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">N.</namePart><namePart type="family">Hyman</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M. M.</namePart><namePart type="family">Esiri</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Cochius, J. I., Hyman, N., Esiri, M. M.: Creutzfeldt‐Jakob disease in a recipient of human pituitary‐derived gonadotrophin: a second case. J Neurol Neurosurg Psychiatry 1992, 55, 1094–1095.</note><part><date>1992</date><detail type="volume"><caption>vol.</caption><number>55</number></detail><extent unit="pages"><start>1094</start><end>1095</end></extent></part><relatedItem type="host"><titleInfo><title>J Neurol Neurosurg Psychiatry</title></titleInfo><part><date>1992</date><detail type="volume"><caption>vol.</caption><number>55</number></detail><extent unit="pages"><start>1094</start><end>1095</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit33"><titleInfo><title>Creutzfeldt‐Jakob disease in United Kingdom patients treated with human pituitary growth hormone.</title></titleInfo><name type="personal"><namePart type="given">A. J.</namePart><namePart type="family">Swerdlow</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C. D.</namePart><namePart type="family">Higgins</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.</namePart><namePart type="family">Adlard</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M. E.</namePart><namePart type="family">Jones</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Swerdlow, A. J., Higgins, C. D., Adlard, P., Jones, M. E. et al., Creutzfeldt‐Jakob disease in United Kingdom patients treated with human pituitary growth hormone. Neurology 2003, 61, 783–791.</note><part><date>2003</date><detail type="volume"><caption>vol.</caption><number>61</number></detail><extent unit="pages"><start>783</start><end>791</end></extent></part><relatedItem type="host"><titleInfo><title>Neurology</title></titleInfo><part><date>2003</date><detail type="volume"><caption>vol.</caption><number>61</number></detail><extent unit="pages"><start>783</start><end>791</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit34"><titleInfo><title>Creutzfeldt‐Jakob disease in the United States, 1979–1994: using national mortality data to assess the possible occurrence of variant cases</title></titleInfo><name type="personal"><namePart type="given">R. C.</namePart><namePart type="family">Holman</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A. S.</namePart><namePart type="family">Khan</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">E. D.</namePart><namePart type="family">Belay</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">L. B.</namePart><namePart type="family">Schonberger</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Holman, R. C., Khan, A. S., Belay, E. D., Schonberger, L. B.: Creutzfeldt‐Jakob disease in the United States, 1979–1994: using national mortality data to assess the possible occurrence of variant cases. Emerg. Infect. Dis. 1996, 2, 333–337.</note><part><date>1996</date><detail type="volume"><caption>vol.</caption><number>2</number></detail><extent unit="pages"><start>333</start><end>337</end></extent></part><relatedItem type="host"><titleInfo><title>Emerg. Infect. Dis.</title></titleInfo><part><date>1996</date><detail type="volume"><caption>vol.</caption><number>2</number></detail><extent unit="pages"><start>333</start><end>337</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit35"><titleInfo><title>Creutzfeldt‐Jakob disease from contaminated growth hormone extracts in France</title></titleInfo><name type="personal"><namePart type="given">T.</namePart><namePart type="family">Billette de Villemeur</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. P.</namePart><namePart type="family">Deslys</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Pradel</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Soubrié</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Billette de Villemeur, T., Deslys, J. P., Pradel, A., Soubrié, C. et al., Creutzfeldt‐Jakob disease from contaminated growth hormone extracts in France. Neurology 1996, 47, 690–695.</note><part><date>1996</date><detail type="volume"><caption>vol.</caption><number>47</number></detail><extent unit="pages"><start>690</start><end>695</end></extent></part><relatedItem type="host"><titleInfo><title>Neurology</title></titleInfo><part><date>1996</date><detail type="volume"><caption>vol.</caption><number>47</number></detail><extent unit="pages"><start>690</start><end>695</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit36"><titleInfo><title>Creutzfeldt‐Jakob disease 38 years after diagnostic use of human growth hormone.</title></titleInfo><name type="personal"><namePart type="given">E. A.</namePart><namePart type="family">Croes</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G.</namePart><namePart type="family">Roks</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G. H.</namePart><namePart type="family">Jansen</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P. C.</namePart><namePart type="family">Nijssen</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Croes, E. A., Roks, G., Jansen, G. H., Nijssen, P. C. et al., Creutzfeldt‐Jakob disease 38 years after diagnostic use of human growth hormone. Neurol Neurosurg Psychiatry 2002, 72, 792–793.</note><part><date>2002</date><detail type="volume"><caption>vol.</caption><number>72</number></detail><extent unit="pages"><start>792</start><end>793</end></extent></part><relatedItem type="host"><titleInfo><title>Neurol Neurosurg Psychiatry</title></titleInfo><part><date>2002</date><detail type="volume"><caption>vol.</caption><number>72</number></detail><extent unit="pages"><start>792</start><end>793</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit37"><titleInfo><title>Creutzfeldt‐Jakob disease in a recipient of human pituitaryderived gonadotrophin.</title></titleInfo><name type="personal"><namePart type="given">J. I.</namePart><namePart type="family">Cochius</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R. J.</namePart><namePart type="family">Burns</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P. C.</namePart><namePart type="family">Blumbergs</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">K.</namePart><namePart type="family">Mack</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Cochius, J. I., Burns, R. J., Blumbergs, P. C., Mack, K. et al., Creutzfeldt‐Jakob disease in a recipient of human pituitaryderived gonadotrophin. Aust NZ J Med. 1990, 20, 592–593.</note><part><date>1990</date><detail type="volume"><caption>vol.</caption><number>20</number></detail><extent unit="pages"><start>592</start><end>593</end></extent></part><relatedItem type="host"><titleInfo><title>Aust NZ J Med.</title></titleInfo><part><date>1990</date><detail type="volume"><caption>vol.</caption><number>20</number></detail><extent unit="pages"><start>592</start><end>593</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit38"><titleInfo><title>Creutzfeld‐Jacob disease legacy for Australian women treated with human pituitary gonadotropins</title></titleInfo><name type="personal"><namePart type="given">L. J.</namePart><namePart type="family">Dumble</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R. D.</namePart><namePart type="family">Klein</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Dumble, L. J., Klein, R. D.: Creutzfeld‐Jacob disease legacy for Australian women treated with human pituitary gonadotropins. Lancet 1992, 340, 847–848.</note><part><date>1992</date><detail type="volume"><caption>vol.</caption><number>340</number></detail><extent unit="pages"><start>847</start><end>848</end></extent></part><relatedItem type="host"><titleInfo><title>Lancet</title></titleInfo><part><date>1992</date><detail type="volume"><caption>vol.</caption><number>340</number></detail><extent unit="pages"><start>847</start><end>848</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit39"><titleInfo><title>The challenge of emerging and re‐emerging infectious diseases</title></titleInfo><name type="personal"><namePart type="given">D. K.</namePart><namePart type="family">Morens</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G. K.</namePart><namePart type="family">Folkers</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A. S.</namePart><namePart type="family">Fauci</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Morens, D. K., Folkers, G. K., Fauci, A. S.: The challenge of emerging and re‐emerging infectious diseases. Nature 2004, 430, 242–249.</note><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>430</number></detail><extent unit="pages"><start>242</start><end>249</end></extent></part><relatedItem type="host"><titleInfo><title>Nature</title></titleInfo><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>430</number></detail><extent unit="pages"><start>242</start><end>249</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit40"><titleInfo><title>Variant Creutzfeldt‐Jakob disease and the acquired and transmissible spongiform encephalopathies</title></titleInfo><name type="personal"><namePart type="given">C. E.</namePart><namePart type="family">Beisel</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D. M.</namePart><namePart type="family">Morens</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Beisel, C. E., Morens, D. M.: Variant Creutzfeldt‐Jakob disease and the acquired and transmissible spongiform encephalopathies. Clin Infect Dis. 2004, 385, 697–704.</note><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>385</number></detail><extent unit="pages"><start>697</start><end>704</end></extent></part><relatedItem type="host"><titleInfo><title>Clin Infect Dis.</title></titleInfo><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>385</number></detail><extent unit="pages"><start>697</start><end>704</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit41"><titleInfo><title>Chronic wasting disease of elk and deer and Creutzfeldt‐Jakob disease: comparative analysis of the scrapie prion protein</title></titleInfo><name type="personal"><namePart type="given">Z.</namePart><namePart type="family">Xie</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">K. I.</namePart><namePart type="family">O'Rourke</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Z.</namePart><namePart type="family">Dong</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A. L.</namePart><namePart type="family">Jenny</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Xie, Z., O'Rourke, K. I., Dong, Z., Jenny, A. L. et al., Chronic wasting disease of elk and deer and Creutzfeldt‐Jakob disease: comparative analysis of the scrapie prion protein. J Biol Chem. 2006, 281, 4199–4206.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>281</number></detail><extent unit="pages"><start>4199</start><end>4206</end></extent></part><relatedItem type="host"><titleInfo><title>J Biol Chem.</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>281</number></detail><extent unit="pages"><start>4199</start><end>4206</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit42"><titleInfo><title>Colorado surveillance program for chronic wasting disease transmission to humans: lessons from 2 highly suspicious but negative cases.</title></titleInfo><name type="personal"><namePart type="given">C. A.</namePart><namePart type="family">Anderson</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.</namePart><namePart type="family">Bosque</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C. M.</namePart><namePart type="family">Filley</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D. B.</namePart><namePart type="family">Arciniegas</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Anderson, C. A., Bosque, P., Filley, C. M., Arciniegas, D. B. et al., Colorado surveillance program for chronic wasting disease transmission to humans: lessons from 2 highly suspicious but negative cases. Arch Neurol. 2007, 64, 439–441.</note><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>64</number></detail><extent unit="pages"><start>439</start><end>441</end></extent></part><relatedItem type="host"><titleInfo><title>Arch Neurol.</title></titleInfo><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>64</number></detail><extent unit="pages"><start>439</start><end>441</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit43"><titleInfo><title>Current and emerging infectious risks of blood transfusions</title></titleInfo><name type="personal"><namePart type="given">M. P.</namePart><namePart type="family">Busch</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S. H.</namePart><namePart type="family">Kleinman</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G. J.</namePart><namePart type="family">Nemo</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Busch, M. P., Kleinman, S. H., Nemo, G. J.: Current and emerging infectious risks of blood transfusions. JAMA 2003, 289, 959–962.</note><part><date>2003</date><detail type="volume"><caption>vol.</caption><number>289</number></detail><extent unit="pages"><start>959</start><end>962</end></extent></part><relatedItem type="host"><titleInfo><title>JAMA</title></titleInfo><part><date>2003</date><detail type="volume"><caption>vol.</caption><number>289</number></detail><extent unit="pages"><start>959</start><end>962</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit44"><titleInfo><title>Decreasing variability in your cell culture.</title></titleInfo><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Stein</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Stein, A., Decreasing variability in your cell culture. Biotechniques 2007, 43, 228–229.</note><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>43</number></detail><extent unit="pages"><start>228</start><end>229</end></extent></part><relatedItem type="host"><titleInfo><title>Biotechniques</title></titleInfo><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>43</number></detail><extent unit="pages"><start>228</start><end>229</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit45"><titleInfo><title>The development, benefits and disadvantages of serum‐free media.</title></titleInfo><name type="personal"><namePart type="given">S. J.</namePart><namePart type="family">Froud</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Froud, S. J., The development, benefits and disadvantages of serum‐free media. Dev Biol Stand. 1999, 99, 157–16.</note><part><date>1999</date><detail type="volume"><caption>vol.</caption><number>99</number></detail><extent unit="pages"><start>157</start><end>16</end></extent></part><relatedItem type="host"><titleInfo><title>Dev Biol Stand.</title></titleInfo><part><date>1999</date><detail type="volume"><caption>vol.</caption><number>99</number></detail><extent unit="pages"><start>157</start><end>16</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit46"><titleInfo><title>Animal cell cultures: recent achievements and perspectives in the production of biopharmaceuticals</title></titleInfo><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Butler</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Butler, M.: Animal cell cultures: recent achievements and perspectives in the production of biopharmaceuticals. Appl Microbiol Biotechnol. 2005, 68, 283–291.</note><part><date>2005</date><detail type="volume"><caption>vol.</caption><number>68</number></detail><extent unit="pages"><start>283</start><end>291</end></extent></part><relatedItem type="host"><titleInfo><title>Appl Microbiol Biotechnol.</title></titleInfo><part><date>2005</date><detail type="volume"><caption>vol.</caption><number>68</number></detail><extent unit="pages"><start>283</start><end>291</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit47"><titleInfo><title>Implementation of advanced technologies in commercial monoclonal antibody production.</title></titleInfo><name type="personal"><namePart type="given">J. X.</namePart><namePart type="family">Zhou</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">T.</namePart><namePart type="family">Tressel</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">X.</namePart><namePart type="family">Yang</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">T.</namePart><namePart type="family">Seewoester</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Zhou, J. X., Tressel, T., Yang, X., Seewoester, T.: Implementation of advanced technologies in commercial monoclonal antibody production.. Biotechnol J. 2008, Aug. 29.</note><part><date>2008</date></part><relatedItem type="host"><titleInfo><title>Biotechnol J.</title></titleInfo><part><date>2008</date></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit48"><titleInfo><title>Development of serum‐free media for cell growth and production of viruses/viral vaccines – safety issues of animal products used in serum‐free media.</title></titleInfo><name type="personal"><namePart type="given">O. W.</namePart><namePart type="family">Merten</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Merten, O. W.: Development of serum‐free media for cell growth and production of viruses/viral vaccines – safety issues of animal products used in serum‐free media.. Dev Biol (Basel) 2002, 111, 233–257.</note><part><date>2002</date><detail type="volume"><caption>vol.</caption><number>111</number></detail><extent unit="pages"><start>233</start><end>257</end></extent></part><relatedItem type="host"><titleInfo><title>Dev Biol (Basel)</title></titleInfo><part><date>2002</date><detail type="volume"><caption>vol.</caption><number>111</number></detail><extent unit="pages"><start>233</start><end>257</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit49"><titleInfo><title>The role of recombinant proteins in the development of serum‐free media.</title></titleInfo><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Keenan</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Pearson</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Clynes</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Keenan, J., Pearson, D., Clynes, M., The role of recombinant proteins in the development of serum‐free media. Cytotechnology 2006, 50, 49–56.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>50</number></detail><extent unit="pages"><start>49</start><end>56</end></extent></part><relatedItem type="host"><titleInfo><title>Cytotechnology</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>50</number></detail><extent unit="pages"><start>49</start><end>56</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit50"><titleInfo><title>Insulin‐like growth factor‐I and transferrin mediate growth and survival of Chinese hamster ovary cells.</title></titleInfo><name type="personal"><namePart type="given">N. A.</namePart><namePart type="family">Sunstrom</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R. D.</namePart><namePart type="family">Gay</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D. C.</namePart><namePart type="family">Wong</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">N. A.</namePart><namePart type="family">Kitchen</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Sunstrom, N. A., Gay, R. D., Wong, D. C., Kitchen, N. A. et al., Insulin‐like growth factor‐I and transferrin mediate growth and survival of Chinese hamster ovary cells. Biotechnol Prog. 2000, 16, 698–702.</note><part><date>2000</date><detail type="volume"><caption>vol.</caption><number>16</number></detail><extent unit="pages"><start>698</start><end>702</end></extent></part><relatedItem type="host"><titleInfo><title>Biotechnol Prog.</title></titleInfo><part><date>2000</date><detail type="volume"><caption>vol.</caption><number>16</number></detail><extent unit="pages"><start>698</start><end>702</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit51"><titleInfo><title>Effect of von Willebrand factor coexpression on the synthesis and secretion of factor VIII in Chinese hamster ovary cells.</title></titleInfo><name type="personal"><namePart type="given">R. J.</namePart><namePart type="family">Kaufman</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">L.C.</namePart><namePart type="family">Wasley</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.V.</namePart><namePart type="family">Davies</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R. J.</namePart><namePart type="family">Wise</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Kaufman, R. J., Wasley, L.C., Davies, M.V., Wise, R. J. et al., Effect of von Willebrand factor coexpression on the synthesis and secretion of factor VIII in Chinese hamster ovary cells. Mol Cell Biol. 1989, 9, 1233–1242.</note><part><date>1989</date><detail type="volume"><caption>vol.</caption><number>9</number></detail><extent unit="pages"><start>1233</start><end>1242</end></extent></part><relatedItem type="host"><titleInfo><title>Mol Cell Biol.</title></titleInfo><part><date>1989</date><detail type="volume"><caption>vol.</caption><number>9</number></detail><extent unit="pages"><start>1233</start><end>1242</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit52"><titleInfo><title>Viral infectivity of albumin and plasma protein fraction.</title></titleInfo><name type="personal"><namePart type="given">B. L.</namePart><namePart type="family">Erstad</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Erstad, B. L., Viral infectivity of albumin and plasma protein fraction. Pharmacotherapy 1996, 16, 996–1001.</note><part><date>1996</date><detail type="volume"><caption>vol.</caption><number>16</number></detail><extent unit="pages"><start>996</start><end>1001</end></extent></part><relatedItem type="host"><titleInfo><title>Pharmacotherapy</title></titleInfo><part><date>1996</date><detail type="volume"><caption>vol.</caption><number>16</number></detail><extent unit="pages"><start>996</start><end>1001</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit53"><titleInfo><title>Peters, T. J., The albumin molecule: its structure and chemical properties, in: All About Albumin: Biochemistry, Genetics and Medical Applications. San Diego: Academic Press 1996, pp. 9–75.</title></titleInfo><genre>other</genre></relatedItem><relatedItem type="references" displayLabel="cit54"><titleInfo><title>Heterogeneity and oxidation status of commercial human albumin preparations in clinical use.</title></titleInfo><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Berezenko</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Berezenko, S., Heterogeneity and oxidation status of commercial human albumin preparations in clinical use. Crit Care Med. 2006, 34, 1291.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>34</number></detail><extent unit="pages"><start>1291</start></extent></part><relatedItem type="host"><titleInfo><title>Crit Care Med.</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>34</number></detail><extent unit="pages"><start>1291</start></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit55"><titleInfo><title>Recombinant human albumin as a stabilizer for biological materials and for the preparation of international reference reagents.</title></titleInfo><name type="personal"><namePart type="given">E.</namePart><namePart type="family">Tarelli</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Mire‐Sluis</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H. A.</namePart><namePart type="family">Tivnann</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B.</namePart><namePart type="family">Bolgiano</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Tarelli, E., Mire‐Sluis, A., Tivnann, H. A., Bolgiano, B. et al., Recombinant human albumin as a stabilizer for biological materials and for the preparation of international reference reagents. Biologicals 1998, 26, 331–346.</note><part><date>1998</date><detail type="volume"><caption>vol.</caption><number>26</number></detail><extent unit="pages"><start>331</start><end>346</end></extent></part><relatedItem type="host"><titleInfo><title>Biologicals</title></titleInfo><part><date>1998</date><detail type="volume"><caption>vol.</caption><number>26</number></detail><extent unit="pages"><start>331</start><end>346</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit56"><titleInfo><title>Stabilization of proteins by recombinant human gelatins.</title></titleInfo><name type="personal"><namePart type="given">N.</namePart><namePart type="family">Thyagarajapuram</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Olsen</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C. R.</namePart><namePart type="family">Middaugh</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Thyagarajapuram, N., Olsen, D., Middaugh, C. R., Stabilization of proteins by recombinant human gelatins. Pharm Sci. 2007, 96, 3304–3315.</note><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>96</number></detail><extent unit="pages"><start>3304</start><end>3315</end></extent></part><relatedItem type="host"><titleInfo><title>Pharm Sci.</title></titleInfo><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>96</number></detail><extent unit="pages"><start>3304</start><end>3315</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit57"><titleInfo><title>The structure, stability, and complex behavior of recombinant human gelatins.</title></titleInfo><name type="personal"><namePart type="given">N.</namePart><namePart type="family">Thyagarajapuram</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Olsen</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C. R.</namePart><namePart type="family">Middaugh</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Thyagarajapuram, N., Olsen, D., Middaugh, C. R., The structure, stability, and complex behavior of recombinant human gelatins. Pharm Sci. 2007, 96, 3363–3378.</note><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>96</number></detail><extent unit="pages"><start>3363</start><end>3378</end></extent></part><relatedItem type="host"><titleInfo><title>Pharm Sci.</title></titleInfo><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>96</number></detail><extent unit="pages"><start>3363</start><end>3378</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit58"><titleInfo><title>Structure‐immunogenicity relationships of therapeutic proteins.</title></titleInfo><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Hermeling</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D. J.</namePart><namePart type="family">Crommelin</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Schellekens</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">W.</namePart><namePart type="family">Jiskoot</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Hermeling, S., Crommelin, D. J., Schellekens, H., Jiskoot, W., Structure‐immunogenicity relationships of therapeutic proteins. Pharm Res. 2004, 21, 897–903.</note><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>21</number></detail><extent unit="pages"><start>897</start><end>903</end></extent></part><relatedItem type="host"><titleInfo><title>Pharm Res.</title></titleInfo><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>21</number></detail><extent unit="pages"><start>897</start><end>903</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit59"><titleInfo><title>A role for protein misfolding in immunogenicity of biopharmaceuticals.</title></titleInfo><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Maas</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Hermeling</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B.</namePart><namePart type="family">Bouma</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">W.</namePart><namePart type="family">Jiskoot</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Maas, C., Hermeling, S., Bouma, B., Jiskoot, W. et al., A role for protein misfolding in immunogenicity of biopharmaceuticals. Biol Chem. 2007, 282, 2229–223.</note><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>282</number></detail><extent unit="pages"><start>2229</start><end>223</end></extent></part><relatedItem type="host"><titleInfo><title>Biol Chem.</title></titleInfo><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>282</number></detail><extent unit="pages"><start>2229</start><end>223</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit60"><titleInfo><title>Antibody response to aggregated human interferon alpha2b in wild‐type and transgenic immune tolerant mice depends on type and level of aggregation.</title></titleInfo><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Hermeling</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Schellekens</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Maas</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.F.</namePart><namePart type="family">Gebbink</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Hermeling, S., Schellekens, H., Maas, C., Gebbink, M.F. et al., Antibody response to aggregated human interferon alpha2b in wild‐type and transgenic immune tolerant mice depends on type and level of aggregation. Pharm Sci. 2006, 95, 1084–1096.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>95</number></detail><extent unit="pages"><start>1084</start><end>1096</end></extent></part><relatedItem type="host"><titleInfo><title>Pharm Sci.</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>95</number></detail><extent unit="pages"><start>1084</start><end>1096</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit61"><titleInfo><title>Long‐term stabilization of recombinant human interferon alpha 2b in aqueous solution without serum albumin.</title></titleInfo><name type="personal"><namePart type="given">L.</namePart><namePart type="family">Ruiz</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">N.</namePart><namePart type="family">Reyes</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">L.</namePart><namePart type="family">Duany</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Franco</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Ruiz, L., Reyes, N., Duany, L., Franco, A. et al., Long‐term stabilization of recombinant human interferon alpha 2b in aqueous solution without serum albumin. Int J Pharm. 2003, 264, 57–72.</note><part><date>2003</date><detail type="volume"><caption>vol.</caption><number>264</number></detail><extent unit="pages"><start>57</start><end>72</end></extent></part><relatedItem type="host"><titleInfo><title>Int J Pharm.</title></titleInfo><part><date>2003</date><detail type="volume"><caption>vol.</caption><number>264</number></detail><extent unit="pages"><start>57</start><end>72</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit62"><titleInfo><title>The Rebif new formulation story: it's not trials and error.</title></titleInfo><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Jaber</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R.</namePart><namePart type="family">Driebergen</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G.</namePart><namePart type="family">Giovannoni</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Schellekens</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Jaber, A., Driebergen, R., Giovannoni, G., Schellekens, H. et al., The Rebif new formulation story: it's not trials and error. Drugs R D. 2007, 8, 335–348.</note><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>8</number></detail><extent unit="pages"><start>335</start><end>348</end></extent></part><relatedItem type="host"><titleInfo><title>Drugs R D.</title></titleInfo><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>8</number></detail><extent unit="pages"><start>335</start><end>348</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit63"><titleInfo><title>Safety and immunogenicity of a new formulation of interferon â1a (Rebif(R) New Formulation) in a Phase IIIb study in patients with relapsing multiple sclerosis: 96‐week results</title></titleInfo><name type="personal"><namePart type="given">G.</namePart><namePart type="family">Giovannoni</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">O.</namePart><namePart type="family">Barbarash</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">F.</namePart><namePart type="family">Casset‐Semanaz</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">King</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Giovannoni, G., Barbarash, O., Casset‐Semanaz, F., King, J. et al., Safety and immunogenicity of a new formulation of interferon â1a (Rebif(R) New Formulation) in a Phase IIIb study in patients with relapsing multiple sclerosis: 96‐week results. Mult Scler. 2008, Aug. 28. 25, –.</note><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>25</number></detail></part><relatedItem type="host"><titleInfo><title>Mult Scler.</title></titleInfo><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>25</number></detail></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit64"><titleInfo><title>The therapeutic antibodies market to 2008.</title></titleInfo><name type="personal"><namePart type="given">A. K.</namePart><namePart type="family">Pavlou</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M. J.</namePart><namePart type="family">Belsey</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Pavlou, A. K., Belsey, M. J., The therapeutic antibodies market to 2008. Eur J Pharm Biopharm. 2005, 59, 389–396.</note><part><date>2005</date><detail type="volume"><caption>vol.</caption><number>59</number></detail><extent unit="pages"><start>389</start><end>396</end></extent></part><relatedItem type="host"><titleInfo><title>Eur J Pharm Biopharm.</title></titleInfo><part><date>2005</date><detail type="volume"><caption>vol.</caption><number>59</number></detail><extent unit="pages"><start>389</start><end>396</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit65"><titleInfo><title>Advances in antibody manufacturing using mammalian cells.</title></titleInfo><name type="personal"><namePart type="given">K. J.</namePart><namePart type="family">Morrow Jr.</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Morrow, K. J. Jr.: Advances in antibody manufacturing using mammalian cells.. Biotechnol Annu Rev. 2007, 13, 95–113.</note><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>13</number></detail><extent unit="pages"><start>95</start><end>113</end></extent></part><relatedItem type="host"><titleInfo><title>Biotechnol Annu Rev.</title></titleInfo><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>13</number></detail><extent unit="pages"><start>95</start><end>113</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit66"><titleInfo><title>Safety issues of animal products used in serum‐free media.</title></titleInfo><name type="personal"><namePart type="given">O. W.</namePart><namePart type="family">Merten</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Merten, O. W., Safety issues of animal products used in serum‐free media. Dev Biol Stand. 1999, 99, 167–180.</note><part><date>1999</date><detail type="volume"><caption>vol.</caption><number>99</number></detail><extent unit="pages"><start>167</start><end>180</end></extent></part><relatedItem type="host"><titleInfo><title>Dev Biol Stand.</title></titleInfo><part><date>1999</date><detail type="volume"><caption>vol.</caption><number>99</number></detail><extent unit="pages"><start>167</start><end>180</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit67"><titleInfo><title>Serum‐free hybridoma culture: ethical, scientific and safety considerations.</title></titleInfo><name type="personal"><namePart type="given">M. S.</namePart><namePart type="family">Even</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C. B.</namePart><namePart type="family">Sandusky</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">N. D.</namePart><namePart type="family">Barnard</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Even, M. S., Sandusky, C. B., Barnard, N. D., Serum‐free hybridoma culture: ethical, scientific and safety considerations. Trends Biotechnol. 2006, 24, 105–108.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>24</number></detail><extent unit="pages"><start>105</start><end>108</end></extent></part><relatedItem type="host"><titleInfo><title>Trends Biotechnol.</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>24</number></detail><extent unit="pages"><start>105</start><end>108</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit68"><titleInfo><title>Clinical implications of emerging pathogens in haemophilia: the variant Creutzfeldt‐Jakob disease experience.</title></titleInfo><name type="personal"><namePart type="given">G.</namePart><namePart type="family">Dolan</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Dolan, G., Clinical implications of emerging pathogens in haemophilia: the variant Creutzfeldt‐Jakob disease experience. Haemophilia 2006, 12, Suppl 1, 16–20.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>12</number></detail><detail type="issue"><caption>no.</caption><number>Suppl 1</number></detail><extent unit="pages"><start>16</start><end>20</end></extent></part><relatedItem type="host"><titleInfo><title>Haemophilia</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>12</number></detail><detail type="issue"><caption>no.</caption><number>Suppl 1</number></detail><extent unit="pages"><start>16</start><end>20</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit69"><titleInfo><title>Blood safety and the choice of anti‐hemophilic factor concentrate.</title></titleInfo><name type="personal"><namePart type="given">L. A.</namePart><namePart type="family">Valentino</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">V. M.</namePart><namePart type="family">Oza</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Valentino, L. A., Oza, V. M., Blood safety and the choice of anti‐hemophilic factor concentrate. Pediatr Blood Cancer 2006, 47, 245–254.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>47</number></detail><extent unit="pages"><start>245</start><end>254</end></extent></part><relatedItem type="host"><titleInfo><title>Pediatr Blood Cancer</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>47</number></detail><extent unit="pages"><start>245</start><end>254</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit70"><titleInfo><title>Current risk for transfusion transmitted infections.</title></titleInfo><name type="personal"><namePart type="given">R.Y.</namePart><namePart type="family">Dodd</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Dodd, R.Y., Current risk for transfusion transmitted infections. Curr Opin Hematol. 2007, 14, 671–676.</note><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>14</number></detail><extent unit="pages"><start>671</start><end>676</end></extent></part><relatedItem type="host"><titleInfo><title>Curr Opin Hematol.</title></titleInfo><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>14</number></detail><extent unit="pages"><start>671</start><end>676</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit71"><titleInfo><title>Clinical presentation and pre‐mortem diagnosis of variant Creutzfeldt‐Jakob disease associated with blood transfusion: a case report.</title></titleInfo><name type="personal"><namePart type="given">S. J.</namePart><namePart type="family">Wroe</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Pal</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Siddique</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Hyare</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Wroe, S. J., Pal, S., Siddique, D., Hyare, H. et al., Clinical presentation and pre‐mortem diagnosis of variant Creutzfeldt‐Jakob disease associated with blood transfusion: a case report. Lancet 2006, 368, 2061–2067.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>368</number></detail><extent unit="pages"><start>2061</start><end>2067</end></extent></part><relatedItem type="host"><titleInfo><title>Lancet</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>368</number></detail><extent unit="pages"><start>2061</start><end>2067</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit72"><titleInfo><title>Consideration in hemophilia therapy selection.</title></titleInfo><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Pipe</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Pipe, S., Consideration in hemophilia therapy selection. Semin Hematol. 2006, 43, (2 Suppl 3), S23–27.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>43</number></detail><detail type="issue"><caption>no.</caption><number>2 Suppl 3</number></detail><extent unit="pages"><start>S23</start><end>27</end></extent></part><relatedItem type="host"><titleInfo><title>Semin Hematol.</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>43</number></detail><detail type="issue"><caption>no.</caption><number>2 Suppl 3</number></detail><extent unit="pages"><start>S23</start><end>27</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit73"><titleInfo><title>Infectious disease in the blood supply and the public health response.</title></titleInfo><name type="personal"><namePart type="given">B.</namePart><namePart type="family">Evatt</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Evatt, B., Infectious disease in the blood supply and the public health response. Semin Hematol. 2006, 43, (2 Suppl 3), S4–9.</note><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>43</number></detail><detail type="issue"><caption>no.</caption><number>2 Suppl 3</number></detail><extent unit="pages"><start>S4</start><end>9</end></extent></part><relatedItem type="host"><titleInfo><title>Semin Hematol.</title></titleInfo><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>43</number></detail><detail type="issue"><caption>no.</caption><number>2 Suppl 3</number></detail><extent unit="pages"><start>S4</start><end>9</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit74"><titleInfo><title>EMEA, Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01.Rev2, adopted July 2004). Official Journal of the European Union, http://www.emea.europa.eu/pdfs/human/bwp/TSE%20NFG%20410‐rev2.pdf</title></titleInfo><genre>other</genre></relatedItem><relatedItem type="references" displayLabel="cit75"><titleInfo><title>CPMP, Core SPC for human plasma derived and recombinant coagulation factor VIII products. 2000, June 29, 1–7, http://www.emea.europa.eu/pdfs/human/bpwg/161999en.pdf</title></titleInfo><genre>other</genre></relatedItem><relatedItem type="references" displayLabel="cit76"><titleInfo><title>NHF, MASAC recommendations concerning the treatment of hemophilia and other bleeding disorders. MASAC recommendation #182, 2008, April, http://www.hemophilia.org</title></titleInfo><genre>other</genre></relatedItem><relatedItem type="references" displayLabel="cit77"><titleInfo><title>Guideline on the selection and use of therapeutic products to treat haemophilia and other hereditary bleeding disorders.</title></titleInfo><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Keeling</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Tait</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Makris</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Keeling, D., Tait, C., Makris, M., Guideline on the selection and use of therapeutic products to treat haemophilia and other hereditary bleeding disorders. Haemophilia 2008, 14, 671–684.</note><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>14</number></detail><extent unit="pages"><start>671</start><end>684</end></extent></part><relatedItem type="host"><titleInfo><title>Haemophilia</title></titleInfo><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>14</number></detail><extent unit="pages"><start>671</start><end>684</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit78"><titleInfo><title>CHS, CHS Policy on Blood, Blood Products and their Alternatives. 2003, May 15, http://www.hemophilia.ca/en/1.2.1.php</title></titleInfo><genre>other</genre></relatedItem><relatedItem type="references" displayLabel="cit79"><titleInfo><title>FDA, Points to consider in the characterization of cell lines used to produce biologicals. 1993, July 12, http://www.fda. gov/CBER/gdlns/ptccell.pdf</title></titleInfo><genre>other</genre></relatedItem><relatedItem type="references" displayLabel="cit80"><titleInfo><title>FDA, Guidance for Industry. Characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases. 2006‐Draft, http://www.fda.gov/Cber/gdlns/vaccsubstrates.pdf</title></titleInfo><genre>other</genre></relatedItem><relatedItem type="references" displayLabel="cit81"><titleInfo><title>ICH, Q5A(R1): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. 1997, March, http://www.ich.org/LOB/media/MEDIA425.pdf</title></titleInfo><genre>other</genre></relatedItem><relatedItem type="references" displayLabel="cit82"><titleInfo><title>ICH, Q5D: Derivation and characterisation of cell substrates used for production of biotechnological/biological products. 1997, July, http://www.ich.org/LOB/media/MEDIA429.pdf</title></titleInfo><genre>other</genre></relatedItem><relatedItem type="references" displayLabel="cit83"><titleInfo><title>Evidence of porcine endogenous retroviruses in porcine factor VIII and evaluation of transmission to recipients with hemophilia.</title></titleInfo><name type="personal"><namePart type="given">W.</namePart><namePart type="family">Heneine</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">W. M.</namePart><namePart type="family">Switzer</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. M.</namePart><namePart type="family">Soucie</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B. L.</namePart><namePart type="family">Evatt</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Heneine, W., Switzer, W. M., Soucie, J. M., Evatt, B. L. et al., Evidence of porcine endogenous retroviruses in porcine factor VIII and evaluation of transmission to recipients with hemophilia. Infect Dis. 2001, 183, 648–652.</note><part><date>2001</date><detail type="volume"><caption>vol.</caption><number>183</number></detail><extent unit="pages"><start>648</start><end>652</end></extent></part><relatedItem type="host"><titleInfo><title>Infect Dis.</title></titleInfo><part><date>2001</date><detail type="volume"><caption>vol.</caption><number>183</number></detail><extent unit="pages"><start>648</start><end>652</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit84"><titleInfo><title>Canadian PRCA Focus Group. Anti‐erythropoietin antibody‐mediated pure red cell aplasia after treatment with recombinant erythropoietin products: recommendations for minimization of risk.</title></titleInfo><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Cournoyer</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">E. B.</namePart><namePart type="family">Toffelmire</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G. A.</namePart><namePart type="family">Wells</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D. L.</namePart><namePart type="family">Barber</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Cournoyer, D., Toffelmire, E. B., Wells, G. A., Barber, D. L. et al., Canadian PRCA Focus Group. Anti‐erythropoietin antibody‐mediated pure red cell aplasia after treatment with recombinant erythropoietin products: recommendations for minimization of risk. Am Soc Nephrol. 2004, 15, 2728–2734.</note><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>15</number></detail><extent unit="pages"><start>2728</start><end>2734</end></extent></part><relatedItem type="host"><titleInfo><title>Am Soc Nephrol.</title></titleInfo><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>15</number></detail><extent unit="pages"><start>2728</start><end>2734</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit85"><titleInfo><title>Pure red‐cell aplasia due to anti‐erythropoietin antibodies.</title></titleInfo><name type="personal"><namePart type="given">K. U.</namePart><namePart type="family">Eckardt</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">N.</namePart><namePart type="family">Casadevall</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Eckardt, K. U., Casadevall, N., Pure red‐cell aplasia due to anti‐erythropoietin antibodies. Nephrol Dial Transplant. 2003, 18, 865–869.</note><part><date>2003</date><detail type="volume"><caption>vol.</caption><number>18</number></detail><extent unit="pages"><start>865</start><end>869</end></extent></part><relatedItem type="host"><titleInfo><title>Nephrol Dial Transplant.</title></titleInfo><part><date>2003</date><detail type="volume"><caption>vol.</caption><number>18</number></detail><extent unit="pages"><start>865</start><end>869</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit86"><titleInfo><title>Differences in the glycosylation profile of a monoclonal antibody produced by hybridomas cultured in serum‐supplemented, serum‐free or chemically defined media.</title></titleInfo><name type="personal"><namePart type="given">J. A.</namePart><namePart type="family">Serrato</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">V.</namePart><namePart type="family">Hernández</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Estrada‐Mondaca</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">L. A.</namePart><namePart type="family">Palomares</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Serrato, J. A., Hernández, V., Estrada‐Mondaca, S., Palomares, L. A. et al., Differences in the glycosylation profile of a monoclonal antibody produced by hybridomas cultured in serum‐supplemented, serum‐free or chemically defined media. Biotechnol Appl Biochem. 2007, 47(Pt2), 113–124.</note><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>47(Pt2)</number></detail><extent unit="pages"><start>113</start><end>124</end></extent></part><relatedItem type="host"><titleInfo><title>Biotechnol Appl Biochem.</title></titleInfo><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>47(Pt2)</number></detail><extent unit="pages"><start>113</start><end>124</end></extent></part></relatedItem></relatedItem><relatedItem type="references" displayLabel="cit87"><titleInfo><title>Anonymous, Abseamed – European Public Assessment Report (Scientific Discussion) 2007, http://www.emea.europa.eu/humandocs/PDFs/EPAR/abseamed/H‐727‐en6.pdf</title></titleInfo><genre>other</genre></relatedItem><relatedItem type="references" displayLabel="cit88"><titleInfo><title>Diseases of protein aggregation and the hunt for potential pharmacological agents.</title></titleInfo><name type="personal"><namePart type="given">S. S.</namePart><namePart type="family">Wang</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. W.</namePart><namePart type="family">Wu</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Yamamoto</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H. S.</namePart><namePart type="family">Liu</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Wang, S. S., Wu, J. W., Yamamoto, S., Liu, H. S., Diseases of protein aggregation and the hunt for potential pharmacological agents. Biotechnol J. 2008, 3, 165–192.</note><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>3</number></detail><extent unit="pages"><start>165</start><end>192</end></extent></part><relatedItem type="host"><titleInfo><title>Biotechnol J.</title></titleInfo><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>3</number></detail><extent unit="pages"><start>165</start><end>192</end></extent></part></relatedItem></relatedItem><identifier type="istex">E40FB9671119F56E8D2E3BE8E8E531FACEEB1163</identifier><identifier type="ark">ark:/67375/WNG-GRH0PWQM-Q</identifier><identifier type="DOI">10.1002/biot.200800241</identifier><identifier type="ArticleID">BIOT200800241</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2009 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim</accessCondition><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-L0C46X92-X">wiley</recordContentSource><recordOrigin>Converted from (version ) to MODS version 3.6.</recordOrigin><recordCreationDate encoding="w3cdtf">2019-11-13</recordCreationDate></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/ark:/67375/WNG-GRH0PWQM-Q/record.json</uri></json:item></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Sante/explor/SrasV1/Data/Istex/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001218 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Istex/Corpus/biblio.hfd -nk 001218 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Sante
|area= SrasV1
|flux= Istex
|étape= Corpus
|type= RBID
|clé= ISTEX:E40FB9671119F56E8D2E3BE8E8E531FACEEB1163
|texte= Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells
}}
| This area was generated with Dilib version V0.6.33. |  |