Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies
Identifieur interne : 000576 ( Istex/Corpus ); précédent : 000575; suivant : 000577Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies
Auteurs : Herbert O. Dichtelmüller ; Lothar Biesert ; Fabrizio Fabbrizzi ; Rodrigo Gajardo ; Albrecht Gröner ; Ilka Von Hoegen ; Juan I. Jorquera ; Christoph Kempf ; Thomas R. Kreil ; Dominique Pifat ; Wendy Osheroff ; Gerhard PoelslerSource :
- Transfusion [ 0041-1132 ] ; 2009-09.
English descriptors
- Teeft :
- Bvdv, Corresponding time points, Data collection, Derivative, Different combinations, Different detergents, Different products, Fviii, Highest reduction factor, Human plasma, Imig, Inactivation, Incubation, Incubation temperature, Incubation temperatures, Incubation time, Incubation times, Infectivity, Ivig, Kinetics, Medicinal products, Plasma derivatives, Ppta, Process variables, Production conditions, Production scale, Protein concentration, Protein concentration temperature, Protein concentrations, Residual infectivity, Robustness, Robustness conditions, Robustness studies, September, Short incubation times, Sinv, Standard concentration, Test viruses, Time point, Time points, Tnbp, Tnbp concentration, Tnbp concentrations, Transfusion, Transfusion volume, Triton, Tween, Vacv, Validation, Vertical bars show, Virus, Virus inactivation, Virus inactivation capacity, Virus inactivation data, Virus inactivation studies, Virus safety, Virus validation studies.
Abstract
BACKGROUND: Solvent/detergent (S/D) treatment is an established virus inactivation technology that has been applied in the manufacture of medicinal products derived from human plasma for more than 20 years. Data on the inactivation of enveloped viruses by S/D treatment collected from seven Plasma Protein Therapeutics Association member companies demonstrate the robustness, reliability, and efficacy of this virus inactivation method. STUDY DESIGN AND METHODS: The results from 308 studies reflecting production conditions as well as technical variables significantly beyond the product release specification were evaluated for virus inactivation, comprising different combinations of solvent and detergent (tri(n‐butyl) phosphate [TNBP]/Tween 80, TNBP/Triton X‐100, TNBP/Na‐cholate) and different products (Factor [F]VIII, F IX, and intravenous and intramuscular immunoglobulins). RESULTS: Neither product class, process temperature, protein concentration, nor pH value has a significant impact on virus inactivation. A variable that did appear to be critical was the concentration of solvent and detergent. CONCLUSION: The data presented here demonstrate the robustness of virus inactivation by S/D treatment for a broad spectrum of enveloped test viruses and process variables. Our data substantiate the fact that no transmission of viruses such as human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or of other enveloped viruses was reported for licensed plasma derivatives since the introduction of S/D treatment.
Url:
DOI: 10.1111/j.1537-2995.2009.02222.x
Links to Exploration step
ISTEX:058DD7219B6C0C70E44BE7678B0CDAEEFEB96436Le document en format XML
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Dichtelmüller</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Biesert, Lothar" sort="Biesert, Lothar" uniqKey="Biesert L" first="Lothar" last="Biesert">Lothar Biesert</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Fabbrizzi, Fabrizio" sort="Fabbrizzi, Fabrizio" uniqKey="Fabbrizzi F" first="Fabrizio" last="Fabbrizzi">Fabrizio Fabbrizzi</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Gajardo, Rodrigo" sort="Gajardo, Rodrigo" uniqKey="Gajardo R" first="Rodrigo" last="Gajardo">Rodrigo Gajardo</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Groner, Albrecht" sort="Groner, Albrecht" uniqKey="Groner A" first="Albrecht" last="Gröner">Albrecht Gröner</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Von Hoegen, Ilka" sort="Von Hoegen, Ilka" uniqKey="Von Hoegen I" first="Ilka" last="Von Hoegen">Ilka Von Hoegen</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: ivonhoegen@pptaglobal.eu</mods:affiliation></affiliation></author><author><name sortKey="Jorquera, Juan I" sort="Jorquera, Juan I" uniqKey="Jorquera J" first="Juan I." last="Jorquera">Juan I. Jorquera</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Kempf, Christoph" sort="Kempf, Christoph" uniqKey="Kempf C" first="Christoph" last="Kempf">Christoph Kempf</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</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>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Pifat, Dominique" sort="Pifat, Dominique" uniqKey="Pifat D" first="Dominique" last="Pifat">Dominique Pifat</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Osheroff, Wendy" sort="Osheroff, Wendy" uniqKey="Osheroff W" first="Wendy" last="Osheroff">Wendy Osheroff</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Poelsler, Gerhard" sort="Poelsler, Gerhard" uniqKey="Poelsler G" first="Gerhard" last="Poelsler">Gerhard Poelsler</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:058DD7219B6C0C70E44BE7678B0CDAEEFEB96436</idno><date when="2009" year="2009">2009</date><idno type="doi">10.1111/j.1537-2995.2009.02222.x</idno><idno type="url">https://api.istex.fr/ark:/67375/WNG-7R250W2Z-3/fulltext.pdf</idno><idno type="wicri:Area/Istex/Corpus">000576</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">000576</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main">Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies</title><author><name sortKey="Dichtelmuller, Herbert O" sort="Dichtelmuller, Herbert O" uniqKey="Dichtelmuller H" first="Herbert O." last="Dichtelmüller">Herbert O. Dichtelmüller</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Biesert, Lothar" sort="Biesert, Lothar" uniqKey="Biesert L" first="Lothar" last="Biesert">Lothar Biesert</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Fabbrizzi, Fabrizio" sort="Fabbrizzi, Fabrizio" uniqKey="Fabbrizzi F" first="Fabrizio" last="Fabbrizzi">Fabrizio Fabbrizzi</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Gajardo, Rodrigo" sort="Gajardo, Rodrigo" uniqKey="Gajardo R" first="Rodrigo" last="Gajardo">Rodrigo Gajardo</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Groner, Albrecht" sort="Groner, Albrecht" uniqKey="Groner A" first="Albrecht" last="Gröner">Albrecht Gröner</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Von Hoegen, Ilka" sort="Von Hoegen, Ilka" uniqKey="Von Hoegen I" first="Ilka" last="Von Hoegen">Ilka Von Hoegen</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: ivonhoegen@pptaglobal.eu</mods:affiliation></affiliation></author><author><name sortKey="Jorquera, Juan I" sort="Jorquera, Juan I" uniqKey="Jorquera J" first="Juan I." last="Jorquera">Juan I. Jorquera</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Kempf, Christoph" sort="Kempf, Christoph" uniqKey="Kempf C" first="Christoph" last="Kempf">Christoph Kempf</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</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>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Pifat, Dominique" sort="Pifat, Dominique" uniqKey="Pifat D" first="Dominique" last="Pifat">Dominique Pifat</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Osheroff, Wendy" sort="Osheroff, Wendy" uniqKey="Osheroff W" first="Wendy" last="Osheroff">Wendy Osheroff</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author><author><name sortKey="Poelsler, Gerhard" sort="Poelsler, Gerhard" uniqKey="Poelsler G" first="Gerhard" last="Poelsler">Gerhard Poelsler</name><affiliation><mods:affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Transfusion</title><title level="j" type="alt">TRANSFUSION</title><idno type="ISSN">0041-1132</idno><idno type="eISSN">1537-2995</idno><imprint><biblScope unit="vol">49</biblScope><biblScope unit="issue">9</biblScope><biblScope unit="page" from="1931">1931</biblScope><biblScope unit="page" to="1943">1943</biblScope><biblScope unit="page-count">13</biblScope><publisher>Blackwell Publishing Inc</publisher><pubPlace>Malden, USA</pubPlace><date type="published" when="2009-09">2009-09</date></imprint><idno type="ISSN">0041-1132</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0041-1132</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Bvdv</term><term>Corresponding time points</term><term>Data collection</term><term>Derivative</term><term>Different combinations</term><term>Different detergents</term><term>Different products</term><term>Fviii</term><term>Highest reduction factor</term><term>Human plasma</term><term>Imig</term><term>Inactivation</term><term>Incubation</term><term>Incubation temperature</term><term>Incubation temperatures</term><term>Incubation time</term><term>Incubation times</term><term>Infectivity</term><term>Ivig</term><term>Kinetics</term><term>Medicinal products</term><term>Plasma derivatives</term><term>Ppta</term><term>Process variables</term><term>Production conditions</term><term>Production scale</term><term>Protein concentration</term><term>Protein concentration temperature</term><term>Protein concentrations</term><term>Residual infectivity</term><term>Robustness</term><term>Robustness conditions</term><term>Robustness studies</term><term>September</term><term>Short incubation times</term><term>Sinv</term><term>Standard concentration</term><term>Test viruses</term><term>Time point</term><term>Time points</term><term>Tnbp</term><term>Tnbp concentration</term><term>Tnbp concentrations</term><term>Transfusion</term><term>Transfusion volume</term><term>Triton</term><term>Tween</term><term>Vacv</term><term>Validation</term><term>Vertical bars show</term><term>Virus</term><term>Virus inactivation</term><term>Virus inactivation capacity</term><term>Virus inactivation data</term><term>Virus inactivation studies</term><term>Virus safety</term><term>Virus validation studies</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND: Solvent/detergent (S/D) treatment is an established virus inactivation technology that has been applied in the manufacture of medicinal products derived from human plasma for more than 20 years. Data on the inactivation of enveloped viruses by S/D treatment collected from seven Plasma Protein Therapeutics Association member companies demonstrate the robustness, reliability, and efficacy of this virus inactivation method. STUDY DESIGN AND METHODS: The results from 308 studies reflecting production conditions as well as technical variables significantly beyond the product release specification were evaluated for virus inactivation, comprising different combinations of solvent and detergent (tri(n‐butyl) phosphate [TNBP]/Tween 80, TNBP/Triton X‐100, TNBP/Na‐cholate) and different products (Factor [F]VIII, F IX, and intravenous and intramuscular immunoglobulins). RESULTS: Neither product class, process temperature, protein concentration, nor pH value has a significant impact on virus inactivation. A variable that did appear to be critical was the concentration of solvent and detergent. CONCLUSION: The data presented here demonstrate the robustness of virus inactivation by S/D treatment for a broad spectrum of enveloped test viruses and process variables. Our data substantiate the fact that no transmission of viruses such as human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or of other enveloped viruses was reported for licensed plasma derivatives since the introduction of S/D treatment.</div></front></TEI><istex><corpusName>wiley</corpusName><keywords><teeft><json:string>tnbp</json:string><json:string>virus inactivation</json:string><json:string>inactivation</json:string><json:string>incubation time</json:string><json:string>tween</json:string><json:string>production conditions</json:string><json:string>robustness</json:string><json:string>robustness studies</json:string><json:string>triton</json:string><json:string>protein concentration</json:string><json:string>ivig</json:string><json:string>transfusion</json:string><json:string>imig</json:string><json:string>september</json:string><json:string>different combinations</json:string><json:string>different products</json:string><json:string>plasma derivatives</json:string><json:string>bvdv</json:string><json:string>fviii</json:string><json:string>standard concentration</json:string><json:string>sinv</json:string><json:string>vacv</json:string><json:string>tnbp concentrations</json:string><json:string>kinetics</json:string><json:string>ppta</json:string><json:string>time point</json:string><json:string>vertical bars show</json:string><json:string>production scale</json:string><json:string>test viruses</json:string><json:string>infectivity</json:string><json:string>process variables</json:string><json:string>virus</json:string><json:string>derivative</json:string><json:string>incubation temperature</json:string><json:string>transfusion volume</json:string><json:string>virus validation studies</json:string><json:string>incubation</json:string><json:string>validation</json:string><json:string>tnbp concentration</json:string><json:string>virus inactivation data</json:string><json:string>protein concentrations</json:string><json:string>protein concentration temperature</json:string><json:string>highest reduction factor</json:string><json:string>robustness conditions</json:string><json:string>incubation temperatures</json:string><json:string>residual infectivity</json:string><json:string>virus inactivation capacity</json:string><json:string>medicinal products</json:string><json:string>virus inactivation studies</json:string><json:string>data collection</json:string><json:string>corresponding time points</json:string><json:string>incubation times</json:string><json:string>human plasma</json:string><json:string>time points</json:string><json:string>different detergents</json:string><json:string>short incubation times</json:string><json:string>virus safety</json:string></teeft></keywords><author><json:item><name>Herbert O. Dichtelmüller</name><affiliations><json:string>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</json:string></affiliations></json:item><json:item><name>Lothar Biesert</name><affiliations><json:string>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</json:string></affiliations></json:item><json:item><name>Fabrizio Fabbrizzi</name><affiliations><json:string>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</json:string></affiliations></json:item><json:item><name>Rodrigo Gajardo</name><affiliations><json:string>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</json:string></affiliations></json:item><json:item><name>Albrecht Gröner</name><affiliations><json:string>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</json:string></affiliations></json:item><json:item><name>Ilka von Hoegen</name><affiliations><json:string>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</json:string><json:string>E-mail: ivonhoegen@pptaglobal.eu</json:string></affiliations></json:item><json:item><name>Juan I. Jorquera</name><affiliations><json:string>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</json:string></affiliations></json:item><json:item><name>Christoph Kempf</name><affiliations><json:string>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</json:string></affiliations></json:item><json:item><name>Thomas R. Kreil</name><affiliations><json:string>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</json:string></affiliations></json:item><json:item><name>Dominique Pifat</name><affiliations><json:string>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</json:string></affiliations></json:item><json:item><name>Wendy Osheroff</name><affiliations><json:string>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</json:string></affiliations></json:item><json:item><name>Gerhard Poelsler</name><affiliations><json:string>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</json:string></affiliations></json:item></author><articleId><json:string>TRF2222</json:string></articleId><arkIstex>ark:/67375/WNG-7R250W2Z-3</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>article</json:string></originalGenre><abstract>BACKGROUND: Solvent/detergent (S/D) treatment is an established virus inactivation technology that has been applied in the manufacture of medicinal products derived from human plasma for more than 20 years. Data on the inactivation of enveloped viruses by S/D treatment collected from seven Plasma Protein Therapeutics Association member companies demonstrate the robustness, reliability, and efficacy of this virus inactivation method. STUDY DESIGN AND METHODS: The results from 308 studies reflecting production conditions as well as technical variables significantly beyond the product release specification were evaluated for virus inactivation, comprising different combinations of solvent and detergent (tri(n‐butyl) phosphate [TNBP]/Tween 80, TNBP/Triton X‐100, TNBP/Na‐cholate) and different products (Factor [F]VIII, F IX, and intravenous and intramuscular immunoglobulins). RESULTS: Neither product class, process temperature, protein concentration, nor pH value has a significant impact on virus inactivation. A variable that did appear to be critical was the concentration of solvent and detergent. CONCLUSION: The data presented here demonstrate the robustness of virus inactivation by S/D treatment for a broad spectrum of enveloped test viruses and process variables. Our data substantiate the fact that no transmission of viruses such as human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or of other enveloped viruses was reported for licensed plasma derivatives since the introduction of S/D treatment.</abstract><qualityIndicators><score>9.508</score><pdfWordCount>6026</pdfWordCount><pdfCharCount>38660</pdfCharCount><pdfVersion>1.3</pdfVersion><pdfPageCount>13</pdfPageCount><pdfPageSize>594 x 783 pts</pdfPageSize><pdfWordsPerPage>464</pdfWordsPerPage><pdfText>true</pdfText><refBibsNative>true</refBibsNative><abstractWordCount>209</abstractWordCount><abstractCharCount>1537</abstractCharCount><keywordCount>0</keywordCount></qualityIndicators><title>Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies</title><pmid><json:string>19497061</json:string></pmid><genre><json:string>article</json:string></genre><host><title>Transfusion</title><language><json:string>unknown</json:string></language><doi><json:string>10.1111/(ISSN)1537-2995</json:string></doi><issn><json:string>0041-1132</json:string></issn><eissn><json:string>1537-2995</json:string></eissn><publisherId><json:string>TRF</json:string></publisherId><volume>49</volume><issue>9</issue><pages><first>1931</first><last>1943</last><total>13</total></pages><genre><json:string>journal</json:string></genre><subject><json:item><value>BLOOD COMPONENTS</value></json:item><json:item><value>BLOOD COMPONENTS</value></json:item></subject></host><namedEntities><unitex><date><json:string>2009</json:string></date><geogName></geogName><orgName><json:string>Institute of Virology, Frankfurt</json:string><json:string>WHO Expert Committee on Biological Standardization</json:string><json:string>Committee for Proprietary Medicinal Products</json:string><json:string>New York Blood Center</json:string><json:string>Research Triangle Park, North Carolina</json:string><json:string>American Type Culture Collection</json:string></orgName><orgName_funder></orgName_funder><orgName_provider></orgName_provider><persName><json:string>Andreas Immelmann</json:string><json:string>Rolf Klengel</json:string><json:string>Wendy Osheroff</json:string><json:string>Dominique Pifat</json:string><json:string>Rodrigo Gajardo</json:string><json:string>Lothar Biesert</json:string><json:string>Ilka von Hoegen</json:string><json:string>Fabrizio Fabbrizzi</json:string><json:string>L. Studies</json:string><json:string>Christoph Kempf</json:string><json:string>Juan I. Jorquera</json:string><json:string>Thomas R. Kreil</json:string></persName><placeName><json:string>Switzerland</json:string><json:string>Marburg</json:string><json:string>Germany</json:string><json:string>Austria</json:string><json:string>Brussels</json:string><json:string>Vienna</json:string><json:string>Frankfurt</json:string><json:string>Italy</json:string><json:string>Spain</json:string><json:string>Belgium</json:string></placeName><ref_url></ref_url><ref_bibl><json:string>Seitz et al.</json:string></ref_bibl><bibl></bibl></unitex></namedEntities><ark><json:string>ark:/67375/WNG-7R250W2Z-3</json:string></ark><categories><wos><json:string>1 - science</json:string><json:string>2 - hematology</json:string></wos><scienceMetrix><json:string>1 - health sciences</json:string><json:string>2 - clinical medicine</json:string><json:string>3 - cardiovascular system & hematology</json:string></scienceMetrix><scopus><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Hematology</json:string><json:string>1 - Life Sciences</json:string><json:string>2 - Immunology and Microbiology</json:string><json:string>3 - Immunology</json:string><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Immunology and Allergy</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>10.1111/j.1537-2995.2009.02222.x</json:string></doi><id>058DD7219B6C0C70E44BE7678B0CDAEEFEB96436</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-7R250W2Z-3/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-7R250W2Z-3/bundle.zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/ark:/67375/WNG-7R250W2Z-3/fulltext.tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main">Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies</title><title level="a" type="short">SOLVENT/DETERGENT TREATMENT OF PLASMA DERIVATIVES</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Blackwell Publishing Inc</publisher><pubPlace>Malden, USA</pubPlace><availability><licence>© 2009 American Association of Blood Banks</licence></availability><date type="published" when="2009-09"></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">Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies</title><title level="a" type="short">SOLVENT/DETERGENT TREATMENT OF PLASMA DERIVATIVES</title><author xml:id="author-0000"><persName><forename type="first">Herbert O.</forename><surname>Dichtelmüller</surname></persName><affiliation><address><addrLine>From the Biotest AG</addrLine><addrLine>Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</addrLine><country key="US" xml:lang="en">UNITED STATES</country></address></affiliation></author><author xml:id="author-0001"><persName><forename type="first">Lothar</forename><surname>Biesert</surname></persName><affiliation><address><addrLine>From the Biotest AG</addrLine><addrLine>Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</addrLine><country key="US" xml:lang="en">UNITED STATES</country></address></affiliation></author><author xml:id="author-0002"><persName><forename type="first">Fabrizio</forename><surname>Fabbrizzi</surname></persName><affiliation><address><addrLine>From the Biotest AG</addrLine><addrLine>Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</addrLine><country key="US" xml:lang="en">UNITED STATES</country></address></affiliation></author><author xml:id="author-0003"><persName><forename type="first">Rodrigo</forename><surname>Gajardo</surname></persName><affiliation><address><addrLine>From the Biotest AG</addrLine><addrLine>Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</addrLine><country key="US" xml:lang="en">UNITED STATES</country></address></affiliation></author><author xml:id="author-0004"><persName><forename type="first">Albrecht</forename><surname>Gröner</surname></persName><affiliation><address><addrLine>From the Biotest AG</addrLine><addrLine>Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</addrLine><country key="US" xml:lang="en">UNITED STATES</country></address></affiliation></author><author xml:id="author-0005" role="corresp"><persName><forename type="first">Ilka</forename><surname>von Hoegen</surname></persName><affiliation><address><addrLine>From the Biotest AG</addrLine><addrLine>Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</addrLine><country key="US" xml:lang="en">UNITED STATES</country></address></affiliation></author><author xml:id="author-0006"><persName><forename type="first">Juan I.</forename><surname>Jorquera</surname></persName><affiliation><address><addrLine>From the Biotest AG</addrLine><addrLine>Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</addrLine><country key="US" xml:lang="en">UNITED STATES</country></address></affiliation></author><author xml:id="author-0007"><persName><forename type="first">Christoph</forename><surname>Kempf</surname></persName><affiliation><address><addrLine>From the Biotest AG</addrLine><addrLine>Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</addrLine><country key="US" xml:lang="en">UNITED STATES</country></address></affiliation></author><author xml:id="author-0008"><persName><forename type="first">Thomas R.</forename><surname>Kreil</surname></persName><affiliation><address><addrLine>From the Biotest AG</addrLine><addrLine>Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</addrLine><country key="US" xml:lang="en">UNITED STATES</country></address></affiliation></author><author xml:id="author-0009"><persName><forename type="first">Dominique</forename><surname>Pifat</surname></persName><affiliation><address><addrLine>From the Biotest AG</addrLine><addrLine>Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</addrLine><country key="US" xml:lang="en">UNITED STATES</country></address></affiliation></author><author xml:id="author-0010"><persName><forename type="first">Wendy</forename><surname>Osheroff</surname></persName><affiliation><address><addrLine>From the Biotest AG</addrLine><addrLine>Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</addrLine><country key="US" xml:lang="en">UNITED STATES</country></address></affiliation></author><author xml:id="author-0011"><persName><forename type="first">Gerhard</forename><surname>Poelsler</surname></persName><affiliation><address><addrLine>From the Biotest AG</addrLine><addrLine>Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</addrLine><country key="US" xml:lang="en">UNITED STATES</country></address></affiliation></author><idno type="istex">058DD7219B6C0C70E44BE7678B0CDAEEFEB96436</idno><idno type="ark">ark:/67375/WNG-7R250W2Z-3</idno><idno type="DOI">10.1111/j.1537-2995.2009.02222.x</idno><idno type="unit">TRF2222</idno><idno type="toTypesetVersion">file:TRF.TRF2222.pdf</idno></analytic><monogr><title level="j" type="main">Transfusion</title><title level="j" type="alt">TRANSFUSION</title><idno type="pISSN">0041-1132</idno><idno type="eISSN">1537-2995</idno><idno type="book-DOI">10.1111/(ISSN)1537-2995</idno><idno type="book-part-DOI">10.1111/trf.2009.49.issue-9</idno><idno type="product">TRF</idno><idno type="publisherDivision">ST</idno><imprint><biblScope unit="vol">49</biblScope><biblScope unit="issue">9</biblScope><biblScope unit="page" from="1931">1931</biblScope><biblScope unit="page" to="1943">1943</biblScope><biblScope unit="page-count">13</biblScope><publisher>Blackwell Publishing Inc</publisher><pubPlace>Malden, USA</pubPlace><date type="published" when="2009-09"></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"><p><hi rend="bold">BACKGROUND:</hi> Solvent/detergent (S/D) treatment is an established virus inactivation technology that has been applied in the manufacture of medicinal products derived from human plasma for more than 20 years. Data on the inactivation of enveloped viruses by S/D treatment collected from seven Plasma Protein Therapeutics Association member companies demonstrate the robustness, reliability, and efficacy of this virus inactivation method.</p><p><hi rend="bold">STUDY DESIGN AND METHODS:</hi> The results from 308 studies reflecting production conditions as well as technical variables significantly beyond the product release specification were evaluated for virus inactivation, comprising different combinations of solvent and detergent (tri(<hi rend="italic">n</hi>‐butyl) phosphate [TNBP]/Tween 80, TNBP/Triton X‐100, TNBP/Na‐cholate) and different products (Factor [F]VIII, F IX, and intravenous and intramuscular immunoglobulins).</p><p><hi rend="bold">RESULTS:</hi> Neither product class, process temperature, protein concentration, nor pH value has a significant impact on virus inactivation. A variable that did appear to be critical was the concentration of solvent and detergent.</p><p><hi rend="bold">CONCLUSION:</hi> The data presented here demonstrate the robustness of virus inactivation by S/D treatment for a broad spectrum of enveloped test viruses and process variables. Our data substantiate the fact that no transmission of viruses such as human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or of other enveloped viruses was reported for licensed plasma derivatives since the introduction of S/D treatment.</p></abstract><textClass><keywords rend="tocHeading1"><term>BLOOD COMPONENTS</term></keywords><keywords rend="articleCategory"><term>BLOOD COMPONENTS</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-7R250W2Z-3/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 Inc</publisherName><publisherLoc>Malden, USA</publisherLoc></publisherInfo><doi origin="wiley" registered="yes">10.1111/(ISSN)1537-2995</doi><issn type="print">0041-1132</issn><issn type="electronic">1537-2995</issn><idGroup><id type="product" value="TRF"></id><id type="publisherDivision" value="ST"></id></idGroup><titleGroup><title type="main" sort="TRANSFUSION">Transfusion</title></titleGroup></publicationMeta><publicationMeta level="part" position="09109"><doi origin="wiley">10.1111/trf.2009.49.issue-9</doi><numberingGroup><numbering type="journalVolume" number="49">49</numbering><numbering type="journalIssue" number="9">9</numbering></numberingGroup><coverDate startDate="2009-09">September 2009</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="23" status="forIssue"><doi origin="wiley">10.1111/j.1537-2995.2009.02222.x</doi><idGroup><id type="unit" value="TRF2222"></id></idGroup><countGroup><count type="pageTotal" number="13"></count></countGroup><titleGroup><title type="tocHeading1">BLOOD COMPONENTS</title><title type="articleCategory">BLOOD COMPONENTS</title></titleGroup><copyright>© 2009 American Association of Blood Banks</copyright><eventGroup><event type="firstOnline" date="2009-05-20"></event><event type="publishedOnlineFinalForm" date="2009-08-26"></event><event type="publishedOnlineAcceptedOrEarlyUnpaginated" date="2009-05-20"></event><event type="xmlConverted" agent="Converter:BPG_TO_WML3G version:3.2.0 mode:FullText" date="2013-04-01"></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="1931">1931</numbering><numbering type="pageLast" number="1943">1943</numbering></numberingGroup><correspondenceTo>Ilka von Hoegen, PPTA, Boulevard Brand Whitlock 114/5, 1200 Brussels, Belgium; e‐mail: <email>ivonhoegen@pptaglobal.eu</email>.
</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:TRF.TRF2222.pdf"></link></linkGroup></publicationMeta><contentMeta><unparsedEditorialHistory>Received for publication November 4, 2008; revision received March 12, 2009; and accepted March 13, 2009.</unparsedEditorialHistory><countGroup><count type="figureTotal" number="8"></count><count type="tableTotal" number="4"></count><count type="formulaTotal" number="0"></count><count type="referenceTotal" number="19"></count><count type="wordTotal" number="6675"></count><count type="linksPubMed" number="0"></count><count type="linksCrossRef" number="0"></count></countGroup><titleGroup><title type="main">Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies</title><title type="shortAuthors">DICHTELMÜLLER ET AL.</title><title type="short">SOLVENT/DETERGENT TREATMENT OF PLASMA DERIVATIVES</title></titleGroup><creators><creator creatorRole="author" xml:id="cr1" affiliationRef="#a1"><personName><givenNames>Herbert O.</givenNames><familyName>Dichtelmüller</familyName></personName></creator><creator creatorRole="author" xml:id="cr2" affiliationRef="#a1"><personName><givenNames>Lothar</givenNames><familyName>Biesert</familyName></personName></creator><creator creatorRole="author" xml:id="cr3" affiliationRef="#a1"><personName><givenNames>Fabrizio</givenNames><familyName>Fabbrizzi</familyName></personName></creator><creator creatorRole="author" xml:id="cr4" affiliationRef="#a1"><personName><givenNames>Rodrigo</givenNames><familyName>Gajardo</familyName></personName></creator><creator creatorRole="author" xml:id="cr5" affiliationRef="#a1"><personName><givenNames>Albrecht</givenNames><familyName>Gröner</familyName></personName></creator><creator creatorRole="author" xml:id="cr6" affiliationRef="#a1" corresponding="yes"><personName><givenNames>Ilka</givenNames><familyName>von Hoegen</familyName></personName></creator><creator creatorRole="author" xml:id="cr7" affiliationRef="#a1"><personName><givenNames>Juan I.</givenNames><familyName>Jorquera</familyName></personName></creator><creator creatorRole="author" xml:id="cr8" affiliationRef="#a1"><personName><givenNames>Christoph</givenNames><familyName>Kempf</familyName></personName></creator><creator creatorRole="author" xml:id="cr9" affiliationRef="#a1"><personName><givenNames>Thomas R.</givenNames><familyName>Kreil</familyName></personName></creator><creator creatorRole="author" xml:id="cr10" affiliationRef="#a1"><personName><givenNames>Dominique</givenNames><familyName>Pifat</familyName></personName></creator><creator creatorRole="author" xml:id="cr11" affiliationRef="#a1"><personName><givenNames>Wendy</givenNames><familyName>Osheroff</familyName></personName></creator><creator creatorRole="author" xml:id="cr12" affiliationRef="#a1"><personName><givenNames>Gerhard</givenNames><familyName>Poelsler</familyName></personName></creator></creators><affiliationGroup><affiliation xml:id="a1" countryCode="US"><unparsedAffiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</unparsedAffiliation></affiliation></affiliationGroup><supportingInformation><p><b>APPENDIX:</b> DATA OF VIRUS VALIDATION STUDIES</p><p>Please note: Wiley‐Blackwell are not responsible for the content or functionality of any supporting materials supplied by the authors. Any queries (other than missing material) should be directed to the corresponding author for the article.</p><supportingInfoItem><mediaResource alt="supporting info item" href="urn-x:wiley:00411132:media:trf2222:TRF_02222_sm_Appendix"></mediaResource><caption>Supporting info item</caption></supportingInfoItem></supportingInformation><abstractGroup><abstract type="main" xml:lang="en"><p><b>BACKGROUND:</b> Solvent/detergent (S/D) treatment is an established virus inactivation technology that has been applied in the manufacture of medicinal products derived from human plasma for more than 20 years. Data on the inactivation of enveloped viruses by S/D treatment collected from seven Plasma Protein Therapeutics Association member companies demonstrate the robustness, reliability, and efficacy of this virus inactivation method.</p><p><b>STUDY DESIGN AND METHODS:</b> The results from 308 studies reflecting production conditions as well as technical variables significantly beyond the product release specification were evaluated for virus inactivation, comprising different combinations of solvent and detergent (tri(<i>n</i>‐butyl) phosphate [TNBP]/Tween 80, TNBP/Triton X‐100, TNBP/Na‐cholate) and different products (Factor [F]VIII, F IX, and intravenous and intramuscular immunoglobulins).</p><p><b>RESULTS:</b> Neither product class, process temperature, protein concentration, nor pH value has a significant impact on virus inactivation. A variable that did appear to be critical was the concentration of solvent and detergent.</p><p><b>CONCLUSION:</b> The data presented here demonstrate the robustness of virus inactivation by S/D treatment for a broad spectrum of enveloped test viruses and process variables. Our data substantiate the fact that no transmission of viruses such as human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or of other enveloped viruses was reported for licensed plasma derivatives since the introduction of S/D treatment.</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>SOLVENT/DETERGENT TREATMENT OF PLASMA DERIVATIVES</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies</title></titleInfo><name type="personal"><namePart type="given">Herbert O.</namePart><namePart type="family">Dichtelmüller</namePart><affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Lothar</namePart><namePart type="family">Biesert</namePart><affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Fabrizio</namePart><namePart type="family">Fabbrizzi</namePart><affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Rodrigo</namePart><namePart type="family">Gajardo</namePart><affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Albrecht</namePart><namePart type="family">Gröner</namePart><affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ilka</namePart><namePart type="family">von Hoegen</namePart><affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</affiliation><affiliation>E-mail: ivonhoegen@pptaglobal.eu</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Juan I.</namePart><namePart type="family">Jorquera</namePart><affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Christoph</namePart><namePart type="family">Kempf</namePart><affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Thomas R.</namePart><namePart type="family">Kreil</namePart><affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Dominique</namePart><namePart type="family">Pifat</namePart><affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Wendy</namePart><namePart type="family">Osheroff</namePart><affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Gerhard</namePart><namePart type="family">Poelsler</namePart><affiliation>From the Biotest AG, Dreieich, Germany; Octapharma GmbH, Frankfurt, Germany; Kedrion, Castelvecchio Pascoli, Italy; Grifols, Parets del Vallès, Spain; CSL Behring, Marburg, Germany; PPTA, Boulevard Brand Whitlock, Brussels, Belgium; CSL Behring, Berne, Switzerland; Baxter BioScience, Vienna, Austria; and Talecris, Research Triangle Park, North Carolina.</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 Inc</publisher><place><placeTerm type="text">Malden, USA</placeTerm></place><dateIssued encoding="w3cdtf">2009-09</dateIssued><edition>Received for publication November 4, 2008; revision received March 12, 2009; and accepted March 13, 2009.</edition><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">8</extent><extent unit="tables">4</extent><extent unit="formulas">0</extent><extent unit="references">19</extent><extent unit="linksCrossRef">0</extent><extent unit="words">6675</extent></physicalDescription><abstract lang="en">BACKGROUND: Solvent/detergent (S/D) treatment is an established virus inactivation technology that has been applied in the manufacture of medicinal products derived from human plasma for more than 20 years. Data on the inactivation of enveloped viruses by S/D treatment collected from seven Plasma Protein Therapeutics Association member companies demonstrate the robustness, reliability, and efficacy of this virus inactivation method. STUDY DESIGN AND METHODS: The results from 308 studies reflecting production conditions as well as technical variables significantly beyond the product release specification were evaluated for virus inactivation, comprising different combinations of solvent and detergent (tri(n‐butyl) phosphate [TNBP]/Tween 80, TNBP/Triton X‐100, TNBP/Na‐cholate) and different products (Factor [F]VIII, F IX, and intravenous and intramuscular immunoglobulins). RESULTS: Neither product class, process temperature, protein concentration, nor pH value has a significant impact on virus inactivation. A variable that did appear to be critical was the concentration of solvent and detergent. CONCLUSION: The data presented here demonstrate the robustness of virus inactivation by S/D treatment for a broad spectrum of enveloped test viruses and process variables. Our data substantiate the fact that no transmission of viruses such as human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or of other enveloped viruses was reported for licensed plasma derivatives since the introduction of S/D treatment.</abstract><relatedItem type="host"><titleInfo><title>Transfusion</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><note type="content"> APPENDIX: DATA OF VIRUS VALIDATION STUDIES Please note: Wiley‐Blackwell are not responsible for the content or functionality of any supporting materials supplied by the authors. Any queries (other than missing material) should be directed to the corresponding author for the article. APPENDIX: DATA OF VIRUS VALIDATION STUDIES Please note: Wiley‐Blackwell are not responsible for the content or functionality of any supporting materials supplied by the authors. Any queries (other than missing material) should be directed to the corresponding author for the article.Supporting Info Item: Supporting info item - </note><subject><genre>article-category</genre><topic>BLOOD COMPONENTS</topic><topic>BLOOD COMPONENTS</topic></subject><identifier type="ISSN">0041-1132</identifier><identifier type="eISSN">1537-2995</identifier><identifier type="DOI">10.1111/(ISSN)1537-2995</identifier><identifier type="PublisherID">TRF</identifier><part><date>2009</date><detail type="volume"><caption>vol.</caption><number>49</number></detail><detail type="issue"><caption>no.</caption><number>9</number></detail><extent unit="pages"><start>1931</start><end>1943</end><total>13</total></extent></part></relatedItem><relatedItem type="references" displayLabel="cit1"><titleInfo><title>The development of virus‐free labile blood derivatives—a review</title></titleInfo><name type="personal"><namePart type="given">AM</namePart><namePart type="family">Prince</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B</namePart><namePart type="family">Horowitz</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">MS</namePart><namePart type="family">Horowitz</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">E</namePart><namePart type="family">Zang</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Prince AM, Horowitz B, Horowitz MS, Zang E. The development of virus‐free labile blood derivatives—a review. 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