Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies
Identifieur interne : 000D93 ( Main/Exploration ); précédent : 000D92; suivant : 000D94Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies
Auteurs : Herbert O. Dichtelmüller [États-Unis] ; Lothar Biesert [États-Unis] ; Fabrizio Fabbrizzi [États-Unis] ; Rodrigo Gajardo [États-Unis] ; Albrecht Gröner [États-Unis] ; Ilka Von Hoegen [États-Unis] ; Juan I. Jorquera [États-Unis] ; Christoph Kempf [États-Unis] ; Thomas R. Kreil [États-Unis] ; Dominique Pifat [États-Unis] ; Wendy Osheroff [États-Unis] ; Gerhard Poelsler [États-Unis]Source :
- 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
Affiliations:
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Jorquera</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>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</wicri:cityArea></affiliation></author><author><name sortKey="Kempf, Christoph" sort="Kempf, Christoph" uniqKey="Kempf C" first="Christoph" last="Kempf">Christoph Kempf</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>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</wicri:cityArea></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 wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>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</wicri:cityArea></affiliation></author><author><name sortKey="Pifat, Dominique" sort="Pifat, Dominique" uniqKey="Pifat D" first="Dominique" last="Pifat">Dominique Pifat</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>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</wicri:cityArea></affiliation></author><author><name sortKey="Osheroff, Wendy" sort="Osheroff, Wendy" uniqKey="Osheroff W" first="Wendy" last="Osheroff">Wendy Osheroff</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>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</wicri:cityArea></affiliation></author><author><name sortKey="Poelsler, Gerhard" sort="Poelsler, Gerhard" uniqKey="Poelsler G" first="Gerhard" last="Poelsler">Gerhard Poelsler</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>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</wicri:cityArea></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><affiliations><list><country><li>États-Unis</li></country><region><li>Caroline du Nord</li></region></list><tree><country name="États-Unis"><region name="Caroline du Nord"><name sortKey="Dichtelmuller, Herbert O" sort="Dichtelmuller, Herbert O" uniqKey="Dichtelmuller H" first="Herbert O." last="Dichtelmüller">Herbert O. Dichtelmüller</name></region><name sortKey="Biesert, Lothar" sort="Biesert, Lothar" uniqKey="Biesert L" first="Lothar" last="Biesert">Lothar Biesert</name><name sortKey="Fabbrizzi, Fabrizio" sort="Fabbrizzi, Fabrizio" uniqKey="Fabbrizzi F" first="Fabrizio" last="Fabbrizzi">Fabrizio Fabbrizzi</name><name sortKey="Gajardo, Rodrigo" sort="Gajardo, Rodrigo" uniqKey="Gajardo R" first="Rodrigo" last="Gajardo">Rodrigo Gajardo</name><name sortKey="Groner, Albrecht" sort="Groner, Albrecht" uniqKey="Groner A" first="Albrecht" last="Gröner">Albrecht Gröner</name><name sortKey="Jorquera, Juan I" sort="Jorquera, Juan I" uniqKey="Jorquera J" first="Juan I." last="Jorquera">Juan I. Jorquera</name><name sortKey="Kempf, Christoph" sort="Kempf, Christoph" uniqKey="Kempf C" first="Christoph" last="Kempf">Christoph Kempf</name><name sortKey="Kreil, Thomas R" sort="Kreil, Thomas R" uniqKey="Kreil T" first="Thomas R." last="Kreil">Thomas R. Kreil</name><name sortKey="Osheroff, Wendy" sort="Osheroff, Wendy" uniqKey="Osheroff W" first="Wendy" last="Osheroff">Wendy Osheroff</name><name sortKey="Pifat, Dominique" sort="Pifat, Dominique" uniqKey="Pifat D" first="Dominique" last="Pifat">Dominique Pifat</name><name sortKey="Poelsler, Gerhard" sort="Poelsler, Gerhard" uniqKey="Poelsler G" first="Gerhard" last="Poelsler">Gerhard Poelsler</name><name sortKey="Von Hoegen, Ilka" sort="Von Hoegen, Ilka" uniqKey="Von Hoegen I" first="Ilka" last="Von Hoegen">Ilka Von Hoegen</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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