Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells
Identifieur interne : 000139 ( Psycho/Analysis ); précédent : 000138; suivant : 000140Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells
Auteurs : Leopold Grillberger [Autriche] ; Thomas R. Kreil [Autriche] ; Sonia Nasr [États-Unis] ; Manfred Reiter [Autriche]Source :
- 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
Affiliations:
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ISTEX:E40FB9671119F56E8D2E3BE8E8E531FACEEB1163Le document en format XML
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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><affiliations><list><country><li>Autriche</li><li>États-Unis</li></country><region><li>Colorado</li><li>Vienne (Autriche)</li></region><settlement><li>Vienne (Autriche)</li></settlement></list><tree><country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Grillberger, Leopold" sort="Grillberger, Leopold" uniqKey="Grillberger L" first="Leopold" last="Grillberger">Leopold Grillberger</name></region><name sortKey="Kreil, Thomas R" sort="Kreil, Thomas R" uniqKey="Kreil T" first="Thomas R." last="Kreil">Thomas R. Kreil</name><name sortKey="Reiter, Manfred" sort="Reiter, Manfred" uniqKey="Reiter M" first="Manfred" last="Reiter">Manfred Reiter</name></country><country name="États-Unis"><region name="Colorado"><name sortKey="Nasr, Sonia" sort="Nasr, Sonia" uniqKey="Nasr S" first="Sonia" last="Nasr">Sonia Nasr</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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