Solvent‐detergent filtered (S/D‐F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system
Identifieur interne : 000224 ( Istex/Corpus ); précédent : 000223; suivant : 000225Solvent‐detergent filtered (S/D‐F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system
Auteurs : M. El-Ekiaby ; M. A. Sayed ; C. Caron ; S. Burnouf ; N. El-Sharkawy ; H. Goubran ; M. Radosevich ; J. Goudemand ; D. Blum ; L. De Melo ; V. Soulié ; J. Adam ; T. BurnoufSource :
- Transfusion Medicine [ 0958-7578 ] ; 2010-02.
Abstract
summary. Solvent‐detergent (S/D) viral inactivation was recently adapted to the treatment of single plasma donations and cryoprecipitate minipools. We present here a new process and a new bag system where the S/D reagents are removed by filtration and the final products subjected to bacterial (0·2 μm) filtration. Recovered and apheresis plasma for transfusion (FFP) and cryoprecipitate minipools (400 ± 20 mL) were subjected to double‐stage S/D viral inactivation, followed by one oil extraction and a filtration on a S/D and phthalate [di(2‐ethylhexyl) phthalate (DEHP)] adsorption device and a 0·2 μm filter. The initial and the final products were compared for visual appearance, blood cell count and cell markers, proteins functional activity, von Willebrand factor (VWF) multimers and protein profile by sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS–PAGE). Tri (n‐butyl) phosphate (TnBP) was quantified by gas chromatography and Triton X‐45 and DEHP by high‐performance‐liquid chromatography (HPLC). General safety tests were by 6·5 mL/kg intravenous injection in rats. The treated plasmas and cryoprecipitates were very clear and the protein content and functionality, VWF multimers and SDS–PAGE profiles were well preserved. TnBP and Triton X‐45 were < 1 and <25 ppm, respectively, and DEHP (about 5 ppm) was less than it was in the starting materials. Blood cell counts and CD45, CD61 and glycophorin A markers were negative. There was no enhanced toxicity in rats. Thus, plasma and cryoprecipitate can be S/D‐treated in this new CE‐marked disposable integral processing system under conditions preserving protein function and integrity, removing blood cells, S/D agents and DEHP, and ensuring bacterial sterility. This process may offer one additional option to blood establishments for the production of virally inactivated plasma components.
Url:
DOI: 10.1111/j.1365-3148.2009.00963.x
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Caron</name><affiliation><mods:affiliation>Laboratoire d'hématologie, Hôpital Régional et Universitaire Lille</mods:affiliation></affiliation></author><author><name sortKey="Burnouf, S" sort="Burnouf, S" uniqKey="Burnouf S" first="S." last="Burnouf">S. Burnouf</name><affiliation><mods:affiliation>INSERM, U837</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Lille‐Nord de France, IMPRT, Jean‐Pierre Aubert Research Centre</mods:affiliation></affiliation></author><author><name sortKey="El Harkawy, N" sort="El Harkawy, N" uniqKey="El Harkawy N" first="N." last="El-Sharkawy">N. El-Sharkawy</name><affiliation><mods:affiliation>National Cancer Institute</mods:affiliation></affiliation></author><author><name sortKey="Goubran, H" sort="Goubran, H" uniqKey="Goubran H" first="H." last="Goubran">H. 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El-Ekiaby</name><affiliation><mods:affiliation>Shabrawishi Hospital Blood Bank, Giza, Egypt</mods:affiliation></affiliation></author><author><name sortKey="Sayed, M A" sort="Sayed, M A" uniqKey="Sayed M" first="M. A." last="Sayed">M. A. Sayed</name><affiliation><mods:affiliation>Fayoum University, Fayoum, Egypt</mods:affiliation></affiliation></author><author><name sortKey="Caron, C" sort="Caron, C" uniqKey="Caron C" first="C." last="Caron">C. Caron</name><affiliation><mods:affiliation>Laboratoire d'hématologie, Hôpital Régional et Universitaire Lille</mods:affiliation></affiliation></author><author><name sortKey="Burnouf, S" sort="Burnouf, S" uniqKey="Burnouf S" first="S." last="Burnouf">S. Burnouf</name><affiliation><mods:affiliation>INSERM, U837</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Lille‐Nord de France, IMPRT, Jean‐Pierre Aubert Research Centre</mods:affiliation></affiliation></author><author><name sortKey="El Harkawy, N" sort="El Harkawy, N" uniqKey="El Harkawy N" first="N." last="El-Sharkawy">N. El-Sharkawy</name><affiliation><mods:affiliation>National Cancer Institute</mods:affiliation></affiliation></author><author><name sortKey="Goubran, H" sort="Goubran, H" uniqKey="Goubran H" first="H." last="Goubran">H. Goubran</name><affiliation><mods:affiliation>Faculty of Medicine, Cairo University, Cairo, Egypt</mods:affiliation></affiliation></author><author><name sortKey="Radosevich, M" sort="Radosevich, M" uniqKey="Radosevich M" first="M." last="Radosevich">M. Radosevich</name><affiliation><mods:affiliation>Human Protein Process Sciences, Lille, France</mods:affiliation></affiliation></author><author><name sortKey="Goudemand, J" sort="Goudemand, J" uniqKey="Goudemand J" first="J." last="Goudemand">J. Goudemand</name><affiliation><mods:affiliation>Laboratoire d'hématologie, Hôpital Régional et Universitaire Lille</mods:affiliation></affiliation></author><author><name sortKey="Blum, D" sort="Blum, D" uniqKey="Blum D" first="D." last="Blum">D. Blum</name><affiliation><mods:affiliation>INSERM, U837</mods:affiliation></affiliation><affiliation><mods:affiliation>Université Lille‐Nord de France, IMPRT, Jean‐Pierre Aubert Research Centre</mods:affiliation></affiliation></author><author><name sortKey="De Melo, L" sort="De Melo, L" uniqKey="De Melo L" first="L." last="De Melo">L. De Melo</name><affiliation><mods:affiliation>V.I.P.S. SA Virus Inactivation of Plasma Systems, 2013 Colombier, Switzerland</mods:affiliation></affiliation></author><author><name sortKey="Soulie, V" sort="Soulie, V" uniqKey="Soulie V" first="V." last="Soulié">V. Soulié</name><affiliation><mods:affiliation>V.I.P.S. SA Virus Inactivation of Plasma Systems, 2013 Colombier, Switzerland</mods:affiliation></affiliation></author><author><name sortKey="Adam, J" sort="Adam, J" uniqKey="Adam J" first="J." last="Adam">J. Adam</name><affiliation><mods:affiliation>V.I.P.S. SA Virus Inactivation of Plasma Systems, 2013 Colombier, Switzerland</mods:affiliation></affiliation></author><author><name sortKey="Burnouf, T" sort="Burnouf, T" uniqKey="Burnouf T" first="T." last="Burnouf">T. Burnouf</name><affiliation><mods:affiliation>Human Protein Process Sciences, Lille, France</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: tburnou@attglobal.net</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Transfusion Medicine</title><title level="j" type="alt">TRANSFUSION MEDICINE</title><idno type="ISSN">0958-7578</idno><idno type="eISSN">1365-3148</idno><imprint><biblScope unit="vol">20</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="48">48</biblScope><biblScope unit="page" to="61">61</biblScope><biblScope unit="page-count">14</biblScope><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2010-02">2010-02</date></imprint><idno type="ISSN">0958-7578</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0958-7578</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">summary. Solvent‐detergent (S/D) viral inactivation was recently adapted to the treatment of single plasma donations and cryoprecipitate minipools. We present here a new process and a new bag system where the S/D reagents are removed by filtration and the final products subjected to bacterial (0·2 μm) filtration. Recovered and apheresis plasma for transfusion (FFP) and cryoprecipitate minipools (400 ± 20 mL) were subjected to double‐stage S/D viral inactivation, followed by one oil extraction and a filtration on a S/D and phthalate [di(2‐ethylhexyl) phthalate (DEHP)] adsorption device and a 0·2 μm filter. The initial and the final products were compared for visual appearance, blood cell count and cell markers, proteins functional activity, von Willebrand factor (VWF) multimers and protein profile by sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS–PAGE). Tri (n‐butyl) phosphate (TnBP) was quantified by gas chromatography and Triton X‐45 and DEHP by high‐performance‐liquid chromatography (HPLC). General safety tests were by 6·5 mL/kg intravenous injection in rats. The treated plasmas and cryoprecipitates were very clear and the protein content and functionality, VWF multimers and SDS–PAGE profiles were well preserved. TnBP and Triton X‐45 were < 1 and <25 ppm, respectively, and DEHP (about 5 ppm) was less than it was in the starting materials. Blood cell counts and CD45, CD61 and glycophorin A markers were negative. There was no enhanced toxicity in rats. Thus, plasma and cryoprecipitate can be S/D‐treated in this new CE‐marked disposable integral processing system under conditions preserving protein function and integrity, removing blood cells, S/D agents and DEHP, and ensuring bacterial sterility. This process may offer one additional option to blood establishments for the production of virally inactivated plasma components.</div></front></TEI><istex><corpusName>wiley</corpusName><keywords><teeft><json:string>cryoprecipitate</json:string><json:string>transfusion</json:string><json:string>filtration</json:string><json:string>burnouf</json:string><json:string>triton</json:string><json:string>dehp</json:string><json:string>viral</json:string><json:string>apheresis</json:string><json:string>minipools</json:string><json:string>tnbp</json:string><json:string>viii</json:string><json:string>cryoprecipitate minipools</json:string><json:string>transfusion medicine</json:string><json:string>author journal compilation</json:string><json:string>fibrinogen</json:string><json:string>british blood transfusion society</json:string><json:string>willebrand</json:string><json:string>factor viii</json:string><json:string>multimers</json:string><json:string>apheresis plasma</json:string><json:string>plasma material</json:string><json:string>viral inactivation</json:string><json:string>adsorption</json:string><json:string>haemophilia</json:string><json:string>plasma fraction</json:string><json:string>processing system</json:string><json:string>blood cell</json:string><json:string>inactivation</json:string><json:string>plasma</json:string><json:string>functional activity</json:string><json:string>willebrand factor</json:string><json:string>general safety test</json:string><json:string>assay</json:string><json:string>final product</json:string><json:string>blood establishment</json:string><json:string>protein quality</json:string><json:string>reference plasma</json:string><json:string>plasma component</json:string><json:string>sodium dodecyl</json:string><json:string>sterile filtration</json:string><json:string>willebrand disease</json:string><json:string>adsorption filter</json:string><json:string>blood cell count</json:string><json:string>factor xiii</json:string><json:string>coagulation factor</json:string><json:string>plasma product</json:string><json:string>initial plasma</json:string><json:string>significant difference</json:string><json:string>similar result</json:string><json:string>protein profile</json:string><json:string>shabrawishi hospital blood bank</json:string><json:string>extraction</json:string></teeft></keywords><author><json:item><name>M. El‐Ekiaby</name><affiliations><json:string>Shabrawishi Hospital Blood Bank, Giza, Egypt</json:string></affiliations></json:item><json:item><name>M. A. Sayed</name><affiliations><json:string>Fayoum University, Fayoum, Egypt</json:string></affiliations></json:item><json:item><name>C. Caron</name><affiliations><json:string>Laboratoire d'hématologie, Hôpital Régional et Universitaire Lille</json:string></affiliations></json:item><json:item><name>S. Burnouf</name><affiliations><json:string>INSERM, U837</json:string><json:string>Université Lille‐Nord de France, IMPRT, Jean‐Pierre Aubert Research Centre</json:string></affiliations></json:item><json:item><name>N. El‐Sharkawy</name><affiliations><json:string>National Cancer Institute</json:string></affiliations></json:item><json:item><name>H. Goubran</name><affiliations><json:string>Faculty of Medicine, Cairo University, Cairo, Egypt</json:string></affiliations></json:item><json:item><name>M. Radosevich</name><affiliations><json:string>Human Protein Process Sciences, Lille, France</json:string></affiliations></json:item><json:item><name>J. Goudemand</name><affiliations><json:string>Laboratoire d'hématologie, Hôpital Régional et Universitaire Lille</json:string></affiliations></json:item><json:item><name>D. Blum</name><affiliations><json:string>INSERM, U837</json:string><json:string>Université Lille‐Nord de France, IMPRT, Jean‐Pierre Aubert Research Centre</json:string></affiliations></json:item><json:item><name>L. De Melo</name><affiliations><json:string>V.I.P.S. SA Virus Inactivation of Plasma Systems, 2013 Colombier, Switzerland</json:string></affiliations></json:item><json:item><name>V. Soulié</name><affiliations><json:string>V.I.P.S. SA Virus Inactivation of Plasma Systems, 2013 Colombier, Switzerland</json:string></affiliations></json:item><json:item><name>J. Adam</name><affiliations><json:string>V.I.P.S. SA Virus Inactivation of Plasma Systems, 2013 Colombier, Switzerland</json:string></affiliations></json:item><json:item><name>T. Burnouf</name><affiliations><json:string>Human Protein Process Sciences, Lille, France</json:string><json:string>E-mail: tburnou@attglobal.net</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>blood establishments</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>cryoprecipitate</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>FFP</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>filtration</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>plasma</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>solvent‐detergent</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>viral inactivation</value></json:item></subject><articleId><json:string>TME963</json:string></articleId><arkIstex>ark:/67375/WNG-H0QB113P-P</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>article</json:string></originalGenre><abstract>summary. Solvent‐detergent (S/D) viral inactivation was recently adapted to the treatment of single plasma donations and cryoprecipitate minipools. We present here a new process and a new bag system where the S/D reagents are removed by filtration and the final products subjected to bacterial (0·2 μm) filtration. Recovered and apheresis plasma for transfusion (FFP) and cryoprecipitate minipools (400 ± 20 mL) were subjected to double‐stage S/D viral inactivation, followed by one oil extraction and a filtration on a S/D and phthalate [di(2‐ethylhexyl) phthalate (DEHP)] adsorption device and a 0·2 μm filter. The initial and the final products were compared for visual appearance, blood cell count and cell markers, proteins functional activity, von Willebrand factor (VWF) multimers and protein profile by sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS–PAGE). Tri (n‐butyl) phosphate (TnBP) was quantified by gas chromatography and Triton X‐45 and DEHP by high‐performance‐liquid chromatography (HPLC). General safety tests were by 6·5 mL/kg intravenous injection in rats. The treated plasmas and cryoprecipitates were very clear and the protein content and functionality, VWF multimers and SDS–PAGE profiles were well preserved. TnBP and Triton X‐45 were > 1 and >25 ppm, respectively, and DEHP (about 5 ppm) was less than it was in the starting materials. Blood cell counts and CD45, CD61 and glycophorin A markers were negative. There was no enhanced toxicity in rats. Thus, plasma and cryoprecipitate can be S/D‐treated in this new CE‐marked disposable integral processing system under conditions preserving protein function and integrity, removing blood cells, S/D agents and DEHP, and ensuring bacterial sterility. This process may offer one additional option to blood establishments for the production of virally inactivated plasma components.</abstract><qualityIndicators><score>10</score><pdfWordCount>6551</pdfWordCount><pdfCharCount>44282</pdfCharCount><pdfVersion>1.3</pdfVersion><pdfPageCount>14</pdfPageCount><pdfPageSize>595.276 x 782.362 pts</pdfPageSize><pdfWordsPerPage>468</pdfWordsPerPage><pdfText>true</pdfText><refBibsNative>true</refBibsNative><abstractWordCount>272</abstractWordCount><abstractCharCount>1871</abstractCharCount><keywordCount>7</keywordCount></qualityIndicators><title>Solvent‐detergent filtered (S/D‐F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system</title><pmid><json:string>19778318</json:string></pmid><genre><json:string>article</json:string></genre><host><title>Transfusion Medicine</title><language><json:string>unknown</json:string></language><doi><json:string>10.1111/(ISSN)1365-3148</json:string></doi><issn><json:string>0958-7578</json:string></issn><eissn><json:string>1365-3148</json:string></eissn><publisherId><json:string>TME</json:string></publisherId><volume>20</volume><issue>1</issue><pages><first>48</first><last>61</last><total>14</total></pages><genre><json:string>journal</json:string></genre></host><namedEntities><unitex><date><json:string>4000</json:string><json:string>2010</json:string></date><geogName><json:string>Seine</json:string></geogName><orgName><json:string>WHO</json:string><json:string>Sigma-Aldrich Corporation</json:string><json:string>Sigma Chemical</json:string><json:string>Switzerland Received</json:string><json:string>Invitrogen Corporation</json:string><json:string>Cairo University</json:string><json:string>Shabrawishi Hospital Blood Bank, Giza</json:string><json:string>National Cancer Institute</json:string><json:string>Shabrawishi Hospital Blood Bank</json:string><json:string>National Cancer Institute, Cairo, Egypt</json:string><json:string>Shabrawishi Hospital, Cairo, Egypt</json:string><json:string>Burnouf Shabrawishi Hospital Blood Bank, Giza, Egypt</json:string><json:string>France, IMPRT, Jean-Pierre Aubert Research Centre</json:string><json:string>Board of Directors</json:string></orgName><orgName_funder></orgName_funder><orgName_provider></orgName_provider><persName><json:string>Sylvie Hermoire</json:string><json:string>Ahmed Abd-Allah</json:string><json:string>M. A. Sayed</json:string><json:string>A. Sayed</json:string><json:string>Chantal Capy</json:string><json:string>D. Blum</json:string><json:string>Max Mean</json:string><json:string>T. Burnouf</json:string><json:string>Mr</json:string><json:string>Khaled Fathi</json:string><json:string>C. Caron</json:string><json:string>Dr George</json:string><json:string>Nermin Nabil</json:string><json:string>H. Goubran</json:string><json:string>ELISA Asserachrom</json:string><json:string>Min Max</json:string><json:string>N. El-Sharkawy</json:string><json:string>M. Radosevich</json:string><json:string>Inactivation</json:string><json:string>M. El-Ekiaby</json:string><json:string>L. de Melo</json:string><json:string>V. Souli</json:string><json:string>Amr Shabrawishi</json:string><json:string>Anita Manceau</json:string><json:string>S. Burnouf</json:string></persName><placeName><json:string>Saint Jacques</json:string><json:string>Carlsbad</json:string><json:string>Switzerland</json:string><json:string>Germany</json:string><json:string>Saint-Denis</json:string><json:string>Darmstadt</json:string><json:string>San Jose</json:string><json:string>St Herblain</json:string><json:string>MO</json:string><json:string>Milan</json:string><json:string>USA</json:string><json:string>Cairo</json:string><json:string>Dublin</json:string><json:string>CA</json:string><json:string>Ireland</json:string><json:string>MI</json:string><json:string>Egypt</json:string><json:string>France</json:string><json:string>Italy</json:string><json:string>St Louis</json:string><json:string>Lille</json:string><json:string>Bad Honnef</json:string></placeName><ref_url></ref_url><ref_bibl><json:string>Inoue et al., 2005</json:string><json:string>Burnouf et al., 2008</json:string><json:string>Favaloro & Koutts, 1997</json:string><json:string>Farrugia & Giangrande, 2004</json:string><json:string>M. 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<hi rend="smallCaps">summary</hi>. Solvent‐detergent (S/D) viral inactivation was recently adapted to the treatment of single plasma donations and cryoprecipitate minipools. We present here a new process and a new bag system where the S/D reagents are removed by filtration and the final products subjected to bacterial (0·2 μm) filtration. Recovered and apheresis plasma for transfusion (FFP) and cryoprecipitate minipools (400 ± 20 mL) were subjected to double‐stage S/D viral inactivation, followed by one oil extraction and a filtration on a S/D and phthalate [di(2‐ethylhexyl) phthalate (DEHP)] adsorption device and a 0·2 μm filter. The initial and the final products were compared for visual appearance, blood cell count and cell markers, proteins functional activity, von Willebrand factor (VWF) multimers and protein profile by sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS–PAGE). Tri (<hi rend="italic">n</hi>‐butyl) phosphate (TnBP) was quantified by gas chromatography and Triton X‐45 and DEHP by high‐performance‐liquid chromatography (HPLC). General safety tests were by 6·5 mL/kg intravenous injection in rats. The treated plasmas and cryoprecipitates were very clear and the protein content and functionality, VWF multimers and SDS–PAGE profiles were well preserved. TnBP and Triton X‐45 were < 1 and <25 ppm, respectively, and DEHP (about 5 ppm) was less than it was in the starting materials. Blood cell counts and CD45, CD61 and glycophorin A markers were negative. There was no enhanced toxicity in rats. Thus, plasma and cryoprecipitate can be S/D‐treated in this new CE‐marked disposable integral processing system under conditions preserving protein function and integrity, removing blood cells, S/D agents and DEHP, and ensuring bacterial sterility. This process may offer one additional option to blood establishments for the production of virally inactivated plasma components.</p></abstract><textClass><keywords xml:lang="en"><term xml:id="k1">blood establishments</term><term xml:id="k2">cryoprecipitate</term><term xml:id="k3">FFP</term><term xml:id="k4">filtration</term><term xml:id="k5">plasma</term><term xml:id="k6">solvent‐detergent</term><term xml:id="k7">viral inactivation</term></keywords><keywords rend="tocHeading1"><term>ORIGINAL ARTICLES</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-H0QB113P-P/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>Blackwell Publishing Ltd</publisherName><publisherLoc>Oxford, UK</publisherLoc></publisherInfo><doi origin="wiley" registered="yes">10.1111/(ISSN)1365-3148</doi><issn type="print">0958-7578</issn><issn type="electronic">1365-3148</issn><idGroup><id type="product" value="TME"></id><id type="publisherDivision" value="ST"></id></idGroup><titleGroup><title type="main" sort="TRANSFUSION MEDICINE">Transfusion Medicine</title></titleGroup></publicationMeta><publicationMeta level="part" position="02001"><doi origin="wiley">10.1111/tme.2010.20.issue-1</doi><numberingGroup><numbering type="journalVolume" number="20">20</numbering><numbering type="journalIssue" number="1">1</numbering></numberingGroup><coverDate startDate="2010-02">February 2010</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="7" status="forIssue"><doi origin="wiley">10.1111/j.1365-3148.2009.00963.x</doi><idGroup><id type="unit" value="TME963"></id></idGroup><countGroup><count type="pageTotal" number="14"></count></countGroup><titleGroup><title type="tocHeading1">ORIGINAL ARTICLES</title></titleGroup><copyright>© 2009 The Authors. Journal compilation © 2009 British Blood Transfusion Society</copyright><eventGroup><event type="firstOnline" date="2009-09-23"></event><event type="publishedOnlineFinalForm" date="2010-01-04"></event><event type="xmlConverted" agent="Converter:BPG_TO_WML3G version:2.3.2 mode:FullText source:HeaderRef result:HeaderRef" date="2010-03-04"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-02-10"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-11-04"></event></eventGroup><numberingGroup><numbering type="pageFirst" number="48">48</numbering><numbering type="pageLast" number="61">61</numbering></numberingGroup><correspondenceTo>T. Burnouf, PhD, HPPS, 18, rue Saint Jacques, 59800 Lille, France.
Tel.: +33 3 2838 1930; fax: +33 3 2042 1953
e‐mail: <email>tburnou@attglobal.net</email></correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:TME.TME963.pdf"></link></linkGroup></publicationMeta><contentMeta><unparsedEditorialHistory>Received 12 May 2009; accepted for publication 8 July 2009</unparsedEditorialHistory><countGroup><count type="figureTotal" number="7"></count><count type="tableTotal" number="3"></count><count type="formulaTotal" number="0"></count><count type="referenceTotal" number="41"></count></countGroup><titleGroup><title type="main">Solvent‐detergent filtered (S/D‐F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system</title><title type="shortAuthors"><i>M. El‐Ekiaby</i> et al.</title></titleGroup><creators><creator creatorRole="author" xml:id="cr1" affiliationRef="#a1"><personName><givenNames>M.</givenNames><familyName>El‐Ekiaby</familyName></personName></creator><creator creatorRole="author" xml:id="cr2" affiliationRef="#a2"><personName><givenNames>M. A.</givenNames><familyName>Sayed</familyName></personName></creator><creator creatorRole="author" xml:id="cr3" affiliationRef="#a3"><personName><givenNames>C.</givenNames><familyName>Caron</familyName></personName></creator><creator creatorRole="author" xml:id="cr4" affiliationRef="#a4 #a5"><personName><givenNames>S.</givenNames><familyName>Burnouf</familyName></personName></creator><creator creatorRole="author" xml:id="cr5" affiliationRef="#a7"><personName><givenNames>N.</givenNames><familyName>El‐Sharkawy</familyName></personName></creator><creator creatorRole="author" xml:id="cr6" affiliationRef="#a8"><personName><givenNames>H.</givenNames><familyName>Goubran</familyName></personName></creator><creator creatorRole="author" xml:id="cr7" affiliationRef="#a6"><personName><givenNames>M.</givenNames><familyName>Radosevich</familyName></personName></creator><creator creatorRole="author" xml:id="cr8" affiliationRef="#a3"><personName><givenNames>J.</givenNames><familyName>Goudemand</familyName></personName></creator><creator creatorRole="author" xml:id="cr9" affiliationRef="#a4 #a5"><personName><givenNames>D.</givenNames><familyName>Blum</familyName></personName></creator><creator creatorRole="author" xml:id="cr10" affiliationRef="#a9"><personName><givenNames>L.</givenNames><familyName>De Melo</familyName></personName></creator><creator creatorRole="author" xml:id="cr11" affiliationRef="#a9"><personName><givenNames>V.</givenNames><familyName>Soulié</familyName></personName></creator><creator creatorRole="author" xml:id="cr12" affiliationRef="#a9"><personName><givenNames>J.</givenNames><familyName>Adam</familyName></personName></creator><creator creatorRole="author" xml:id="cr13" affiliationRef="#a6" corresponding="yes"><personName><givenNames>T.</givenNames><familyName>Burnouf</familyName></personName></creator></creators><affiliationGroup><affiliation xml:id="a1" countryCode="EG"><unparsedAffiliation><i>Shabrawishi Hospital Blood Bank, Giza, Egypt</i></unparsedAffiliation></affiliation><affiliation xml:id="a2" countryCode="EG"><unparsedAffiliation><i>Fayoum University, Fayoum, Egypt</i></unparsedAffiliation></affiliation><affiliation xml:id="a3"><unparsedAffiliation><i>Laboratoire d'hématologie, Hôpital Régional et Universitaire Lille</i></unparsedAffiliation></affiliation><affiliation xml:id="a4"><unparsedAffiliation><i>INSERM, U837</i></unparsedAffiliation></affiliation><affiliation xml:id="a5" countryCode="FR"><unparsedAffiliation><i>Université Lille‐Nord de France, IMPRT, Jean‐Pierre Aubert Research Centre</i></unparsedAffiliation></affiliation><affiliation xml:id="a6" countryCode="FR"><unparsedAffiliation><i>Human Protein Process Sciences, Lille, France</i></unparsedAffiliation></affiliation><affiliation xml:id="a7"><unparsedAffiliation><i>National Cancer Institute</i></unparsedAffiliation></affiliation><affiliation xml:id="a8" countryCode="EG"><unparsedAffiliation><i>Faculty of Medicine, Cairo University, Cairo, Egypt</i></unparsedAffiliation></affiliation><affiliation xml:id="a9" countryCode="CH"><unparsedAffiliation><i>V.I.P.S. SA Virus Inactivation of Plasma Systems, 2013 Colombier, Switzerland</i></unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en"><keyword xml:id="k1">blood establishments</keyword><keyword xml:id="k2">cryoprecipitate</keyword><keyword xml:id="k3">FFP</keyword><keyword xml:id="k4">filtration</keyword><keyword xml:id="k5">plasma</keyword><keyword xml:id="k6">solvent‐detergent</keyword><keyword xml:id="k7">viral inactivation</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><p> <sc>summary</sc>. Solvent‐detergent (S/D) viral inactivation was recently adapted to the treatment of single plasma donations and cryoprecipitate minipools. We present here a new process and a new bag system where the S/D reagents are removed by filtration and the final products subjected to bacterial (0·2 μm) filtration. Recovered and apheresis plasma for transfusion (FFP) and cryoprecipitate minipools (400 ± 20 mL) were subjected to double‐stage S/D viral inactivation, followed by one oil extraction and a filtration on a S/D and phthalate [di(2‐ethylhexyl) phthalate (DEHP)] adsorption device and a 0·2 μm filter. The initial and the final products were compared for visual appearance, blood cell count and cell markers, proteins functional activity, von Willebrand factor (VWF) multimers and protein profile by sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS–PAGE). Tri (<i>n</i>‐butyl) phosphate (TnBP) was quantified by gas chromatography and Triton X‐45 and DEHP by high‐performance‐liquid chromatography (HPLC). General safety tests were by 6·5 mL/kg intravenous injection in rats. The treated plasmas and cryoprecipitates were very clear and the protein content and functionality, VWF multimers and SDS–PAGE profiles were well preserved. TnBP and Triton X‐45 were < 1 and <25 ppm, respectively, and DEHP (about 5 ppm) was less than it was in the starting materials. Blood cell counts and CD45, CD61 and glycophorin A markers were negative. There was no enhanced toxicity in rats. Thus, plasma and cryoprecipitate can be S/D‐treated in this new CE‐marked disposable integral processing system under conditions preserving protein function and integrity, removing blood cells, S/D agents and DEHP, and ensuring bacterial sterility. This process may offer one additional option to blood establishments for the production of virally inactivated plasma components.</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Solvent‐detergent filtered (S/D‐F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Solvent‐detergent filtered (S/D‐F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system</title></titleInfo><name type="personal"><namePart type="given">M.</namePart><namePart type="family">El‐Ekiaby</namePart><affiliation>Shabrawishi Hospital Blood Bank, Giza, Egypt</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M. A.</namePart><namePart type="family">Sayed</namePart><affiliation>Fayoum University, Fayoum, Egypt</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Caron</namePart><affiliation>Laboratoire d'hématologie, Hôpital Régional et Universitaire Lille</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Burnouf</namePart><affiliation>INSERM, U837</affiliation><affiliation>Université Lille‐Nord de France, IMPRT, Jean‐Pierre Aubert Research Centre</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">N.</namePart><namePart type="family">El‐Sharkawy</namePart><affiliation>National Cancer Institute</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Goubran</namePart><affiliation>Faculty of Medicine, Cairo University, Cairo, Egypt</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Radosevich</namePart><affiliation>Human Protein Process Sciences, Lille, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Goudemand</namePart><affiliation>Laboratoire d'hématologie, Hôpital Régional et Universitaire Lille</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Blum</namePart><affiliation>INSERM, U837</affiliation><affiliation>Université Lille‐Nord de France, IMPRT, Jean‐Pierre Aubert Research Centre</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">L.</namePart><namePart type="family">De Melo</namePart><affiliation>V.I.P.S. SA Virus Inactivation of Plasma Systems, 2013 Colombier, Switzerland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">V.</namePart><namePart type="family">Soulié</namePart><affiliation>V.I.P.S. SA Virus Inactivation of Plasma Systems, 2013 Colombier, Switzerland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Adam</namePart><affiliation>V.I.P.S. SA Virus Inactivation of Plasma Systems, 2013 Colombier, Switzerland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">T.</namePart><namePart type="family">Burnouf</namePart><affiliation>Human Protein Process Sciences, Lille, France</affiliation><affiliation>E-mail: tburnou@attglobal.net</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>Blackwell Publishing Ltd</publisher><place><placeTerm type="text">Oxford, UK</placeTerm></place><dateIssued encoding="w3cdtf">2010-02</dateIssued><edition>Received 12 May 2009; accepted for publication 8 July 2009</edition><copyrightDate encoding="w3cdtf">2010</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><extent unit="figures">7</extent><extent unit="tables">3</extent><extent unit="formulas">0</extent><extent unit="references">41</extent></physicalDescription><abstract lang="en">summary. Solvent‐detergent (S/D) viral inactivation was recently adapted to the treatment of single plasma donations and cryoprecipitate minipools. We present here a new process and a new bag system where the S/D reagents are removed by filtration and the final products subjected to bacterial (0·2 μm) filtration. Recovered and apheresis plasma for transfusion (FFP) and cryoprecipitate minipools (400 ± 20 mL) were subjected to double‐stage S/D viral inactivation, followed by one oil extraction and a filtration on a S/D and phthalate [di(2‐ethylhexyl) phthalate (DEHP)] adsorption device and a 0·2 μm filter. The initial and the final products were compared for visual appearance, blood cell count and cell markers, proteins functional activity, von Willebrand factor (VWF) multimers and protein profile by sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS–PAGE). Tri (n‐butyl) phosphate (TnBP) was quantified by gas chromatography and Triton X‐45 and DEHP by high‐performance‐liquid chromatography (HPLC). General safety tests were by 6·5 mL/kg intravenous injection in rats. The treated plasmas and cryoprecipitates were very clear and the protein content and functionality, VWF multimers and SDS–PAGE profiles were well preserved. TnBP and Triton X‐45 were < 1 and <25 ppm, respectively, and DEHP (about 5 ppm) was less than it was in the starting materials. Blood cell counts and CD45, CD61 and glycophorin A markers were negative. There was no enhanced toxicity in rats. Thus, plasma and cryoprecipitate can be S/D‐treated in this new CE‐marked disposable integral processing system under conditions preserving protein function and integrity, removing blood cells, S/D agents and DEHP, and ensuring bacterial sterility. 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