SARS-coronavirus (SARS-CoV) and the safety of a solvent/detergent (S/D) treated immunoglobulin preparation
Identifieur interne : 000E39 ( Pmc/Curation ); précédent : 000E38; suivant : 000E40SARS-coronavirus (SARS-CoV) and the safety of a solvent/detergent (S/D) treated immunoglobulin preparation
Auteurs : H. F. Rabenau [Allemagne] ; L. Biesert [Allemagne] ; T. Schmidt [Allemagne] ; G. Bauer [Allemagne] ; J. Cinatl [Allemagne] ; H. W. Doerr [Allemagne]Source :
- Biologicals [ 1045-1056 ] ; 2005.
Abstract
SARS-coronavirus (SARS-CoV) is a newly emerged, highly pathogenic agent that caused over 8000 human infections with nearly 800 deaths between November 2002 and September 2003. While direct person-to-person transmission via respiratory droplets accounted for most cases, other modes have not been ruled out. SARS-CoV viraemia does not seem to reach high titres, however, it has to be excluded that virus transmission may occur via blood transfusion or application of therapeutic plasma products, e.g. fresh-frozen plasma or single components derived thereof. Manufacturing processes of all plasma derivatives are required to comprise dedicated virus inactivation/removal steps. Treatment with a mixture of solvent and detergent (SD) has successfully been applied to inactivate the most members of the transfusion-relevant viruses without affecting therapeutic properties of the products. The SD treatment irreversibly disrupts the lipid envelope of viruses such as HIV, HBV, HCV, HGV and CMV. In this study we evaluated the manufacturing process of an immunoglobulin preparation (OCTAGAM, manufactured by Octapharma Pharmazeutika Produktionsges.m.b.H., Vienna, Austria) for its capacity to inactivate the SARS-CoV. Our results demonstrate that SARS-CoV was completely inactivated below the limit of detection. This was found to occur within 1 min of SD treatment.
Url:
DOI: 10.1016/j.biologicals.2005.01.003
PubMed: 15939287
PubMed Central: 7128630
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Biesert</name><affiliation wicri:level="1"><nlm:aff id="affb">Octapharma Pharmazeutika Produktionsges.m.b.H., Virus & Prion Validation Department, Paul Ehrlich-St 42-44, D – 60596 Frankfurt am Main, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Octapharma Pharmazeutika Produktionsges.m.b.H., Virus & Prion Validation Department, Paul Ehrlich-St 42-44, D – 60596 Frankfurt am Main</wicri:regionArea></affiliation></author><author><name sortKey="Schmidt, T" sort="Schmidt, T" uniqKey="Schmidt T" first="T." last="Schmidt">T. 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Bauer</name><affiliation wicri:level="1"><nlm:aff id="affa">Institute for Medical Virology, Frankfurt am Main University Hospital Medical School, Paul Ehrlich-Str. 40, D – 60596 Frankfurt am Main, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Medical Virology, Frankfurt am Main University Hospital Medical School, Paul Ehrlich-Str. 40, D – 60596 Frankfurt am Main</wicri:regionArea></affiliation></author><author><name sortKey="Cinatl, J" sort="Cinatl, J" uniqKey="Cinatl J" first="J." last="Cinatl">J. Cinatl</name><affiliation wicri:level="1"><nlm:aff id="affa">Institute for Medical Virology, Frankfurt am Main University Hospital Medical School, Paul Ehrlich-Str. 40, D – 60596 Frankfurt am Main, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Medical Virology, Frankfurt am Main University Hospital Medical School, Paul Ehrlich-Str. 40, D – 60596 Frankfurt am Main</wicri:regionArea></affiliation></author><author><name sortKey="Doerr, H W" sort="Doerr, H W" uniqKey="Doerr H" first="H. W." last="Doerr">H. W. 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F." last="Rabenau">H. F. Rabenau</name><affiliation wicri:level="1"><nlm:aff id="affa">Institute for Medical Virology, Frankfurt am Main University Hospital Medical School, Paul Ehrlich-Str. 40, D – 60596 Frankfurt am Main, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Medical Virology, Frankfurt am Main University Hospital Medical School, Paul Ehrlich-Str. 40, D – 60596 Frankfurt am Main</wicri:regionArea></affiliation></author><author><name sortKey="Biesert, L" sort="Biesert, L" uniqKey="Biesert L" first="L." last="Biesert">L. Biesert</name><affiliation wicri:level="1"><nlm:aff id="affb">Octapharma Pharmazeutika Produktionsges.m.b.H., Virus & Prion Validation Department, Paul Ehrlich-St 42-44, D – 60596 Frankfurt am Main, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Octapharma Pharmazeutika Produktionsges.m.b.H., Virus & Prion Validation Department, Paul Ehrlich-St 42-44, D – 60596 Frankfurt am Main</wicri:regionArea></affiliation></author><author><name sortKey="Schmidt, T" sort="Schmidt, T" uniqKey="Schmidt T" first="T." last="Schmidt">T. Schmidt</name><affiliation wicri:level="1"><nlm:aff id="affb">Octapharma Pharmazeutika Produktionsges.m.b.H., Virus & Prion Validation Department, Paul Ehrlich-St 42-44, D – 60596 Frankfurt am Main, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Octapharma Pharmazeutika Produktionsges.m.b.H., Virus & Prion Validation Department, Paul Ehrlich-St 42-44, D – 60596 Frankfurt am Main</wicri:regionArea></affiliation></author><author><name sortKey="Bauer, G" sort="Bauer, G" uniqKey="Bauer G" first="G." last="Bauer">G. Bauer</name><affiliation wicri:level="1"><nlm:aff id="affa">Institute for Medical Virology, Frankfurt am Main University Hospital Medical School, Paul Ehrlich-Str. 40, D – 60596 Frankfurt am Main, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Medical Virology, Frankfurt am Main University Hospital Medical School, Paul Ehrlich-Str. 40, D – 60596 Frankfurt am Main</wicri:regionArea></affiliation></author><author><name sortKey="Cinatl, J" sort="Cinatl, J" uniqKey="Cinatl J" first="J." last="Cinatl">J. Cinatl</name><affiliation wicri:level="1"><nlm:aff id="affa">Institute for Medical Virology, Frankfurt am Main University Hospital Medical School, Paul Ehrlich-Str. 40, D – 60596 Frankfurt am Main, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Medical Virology, Frankfurt am Main University Hospital Medical School, Paul Ehrlich-Str. 40, D – 60596 Frankfurt am Main</wicri:regionArea></affiliation></author><author><name sortKey="Doerr, H W" sort="Doerr, H W" uniqKey="Doerr H" first="H. W." last="Doerr">H. W. Doerr</name><affiliation wicri:level="1"><nlm:aff id="affa">Institute for Medical Virology, Frankfurt am Main University Hospital Medical School, Paul Ehrlich-Str. 40, D – 60596 Frankfurt am Main, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Medical Virology, Frankfurt am Main University Hospital Medical School, Paul Ehrlich-Str. 40, D – 60596 Frankfurt am Main</wicri:regionArea></affiliation></author></analytic><series><title level="j">Biologicals</title><idno type="ISSN">1045-1056</idno><idno type="eISSN">1095-8320</idno><imprint><date when="2005">2005</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>SARS-coronavirus (SARS-CoV) is a newly emerged, highly pathogenic agent that caused over 8000 human infections with nearly 800 deaths between November 2002 and September 2003. While direct person-to-person transmission via respiratory droplets accounted for most cases, other modes have not been ruled out. SARS-CoV viraemia does not seem to reach high titres, however, it has to be excluded that virus transmission may occur via blood transfusion or application of therapeutic plasma products, e.g. fresh-frozen plasma or single components derived thereof. Manufacturing processes of all plasma derivatives are required to comprise dedicated virus inactivation/removal steps. Treatment with a mixture of solvent and detergent (SD) has successfully been applied to inactivate the most members of the transfusion-relevant viruses without affecting therapeutic properties of the products. The SD treatment irreversibly disrupts the lipid envelope of viruses such as HIV, HBV, HCV, HGV and CMV. In this study we evaluated the manufacturing process of an immunoglobulin preparation (OCTAGAM, manufactured by Octapharma Pharmazeutika Produktionsges.m.b.H., Vienna, Austria) for its capacity to inactivate the SARS-CoV. Our results demonstrate that SARS-CoV was completely inactivated below the limit of detection. This was found to occur within 1 min of SD treatment.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Biesert, L" uniqKey="Biesert L">L. Biesert</name></author><author><name sortKey="G Rtner, T" uniqKey="G Rtner T">T. Gärtner</name></author><author><name sortKey="Lemon, S" uniqKey="Lemon S">S. Lemon</name></author><author><name sortKey="Horowitz, B" uniqKey="Horowitz B">B. Horowitz</name></author><author><name sortKey="Suhartono, S" uniqKey="Suhartono S">S. Suhartono</name></author><author><name sortKey="Wang, L" uniqKey="Wang L">L. 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Ng</name></author><author><name sortKey="Ho, M" uniqKey="Ho M">M. Ho</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Spearman, C" uniqKey="Spearman C">C. Spearman</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Wu, J" uniqKey="Wu J">J. Wu</name></author><author><name sortKey="Xu, F" uniqKey="Xu F">F. Xu</name></author><author><name sortKey="Zhou, W" uniqKey="Zhou W">W. Zhou</name></author><author><name sortKey="Feikin, D R" uniqKey="Feikin D">D.R. Feikin</name></author><author><name sortKey="Lin, C Y" uniqKey="Lin C">C.Y. Lin</name></author><author><name sortKey="He, X" uniqKey="He X">X. He</name></author></analytic></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Biologicals</journal-id><journal-id journal-id-type="iso-abbrev">Biologicals</journal-id><journal-title-group><journal-title>Biologicals</journal-title></journal-title-group><issn pub-type="ppub">1045-1056</issn><issn pub-type="epub">1095-8320</issn><publisher><publisher-name>The International Association for Biologicals. Published by Elsevier Ltd.</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">15939287</article-id><article-id pub-id-type="pmc">7128630</article-id><article-id pub-id-type="publisher-id">S1045-1056(05)00018-7</article-id><article-id pub-id-type="doi">10.1016/j.biologicals.2005.01.003</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>SARS-coronavirus (SARS-CoV) and the safety of a solvent/detergent (S/D) treated immunoglobulin preparation</article-title></title-group><contrib-group><contrib contrib-type="author" id="au1"><name><surname>Rabenau</surname><given-names>H.F.</given-names></name><email>rabenau@em.uni-frankfurt.de</email><xref rid="affa" ref-type="aff">a</xref><xref rid="cor1" ref-type="corresp">∗</xref></contrib><contrib contrib-type="author" id="au2"><name><surname>Biesert</surname><given-names>L.</given-names></name><xref rid="affb" ref-type="aff">b</xref></contrib><contrib contrib-type="author" id="au3"><name><surname>Schmidt</surname><given-names>T.</given-names></name><xref rid="affb" ref-type="aff">b</xref></contrib><contrib contrib-type="author" id="au4"><name><surname>Bauer</surname><given-names>G.</given-names></name><xref rid="affa" ref-type="aff">a</xref></contrib><contrib contrib-type="author" id="au5"><name><surname>Cinatl</surname><given-names>J.</given-names></name><xref rid="affa" ref-type="aff">a</xref></contrib><contrib contrib-type="author" id="au6"><name><surname>Doerr</surname><given-names>H.W.</given-names></name><xref rid="affa" ref-type="aff">a</xref></contrib></contrib-group><aff id="affa"><label>a</label>Institute for Medical Virology, Frankfurt am Main University Hospital Medical School, Paul Ehrlich-Str. 40, D – 60596 Frankfurt am Main, Germany</aff><aff id="affb"><label>b</label>Octapharma Pharmazeutika Produktionsges.m.b.H., Virus & Prion Validation Department, Paul Ehrlich-St 42-44, D – 60596 Frankfurt am Main, Germany</aff><author-notes><corresp id="cor1"><label>∗</label>Corresponding author. Tel.: +49 69 6301 5312; fax: +49 69 6301 83061. <email>rabenau@em.uni-frankfurt.de</email></corresp></author-notes><pub-date pub-type="pmc-release"><day>7</day><month>4</month><year>2005</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on .</pmc-comment>
<pub-date pub-type="ppub"><month>6</month><year>2005</year></pub-date><pub-date pub-type="epub"><day>7</day><month>4</month><year>2005</year></pub-date><volume>33</volume><issue>2</issue><fpage>95</fpage><lpage>99</lpage><history><date date-type="received"><day>6</day><month>7</month><year>2004</year></date><date date-type="accepted"><day>12</day><month>1</month><year>2005</year></date></history><permissions><copyright-statement>Copyright © 2005 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.</copyright-statement><copyright-year>2005</copyright-year><copyright-holder>The International Association for Biologicals</copyright-holder><license><license-p>Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.</license-p></license></permissions><abstract><p>SARS-coronavirus (SARS-CoV) is a newly emerged, highly pathogenic agent that caused over 8000 human infections with nearly 800 deaths between November 2002 and September 2003. While direct person-to-person transmission via respiratory droplets accounted for most cases, other modes have not been ruled out. SARS-CoV viraemia does not seem to reach high titres, however, it has to be excluded that virus transmission may occur via blood transfusion or application of therapeutic plasma products, e.g. fresh-frozen plasma or single components derived thereof. Manufacturing processes of all plasma derivatives are required to comprise dedicated virus inactivation/removal steps. Treatment with a mixture of solvent and detergent (SD) has successfully been applied to inactivate the most members of the transfusion-relevant viruses without affecting therapeutic properties of the products. The SD treatment irreversibly disrupts the lipid envelope of viruses such as HIV, HBV, HCV, HGV and CMV. In this study we evaluated the manufacturing process of an immunoglobulin preparation (OCTAGAM, manufactured by Octapharma Pharmazeutika Produktionsges.m.b.H., Vienna, Austria) for its capacity to inactivate the SARS-CoV. Our results demonstrate that SARS-CoV was completely inactivated below the limit of detection. This was found to occur within 1 min of SD treatment.</p></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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