Inactivation of West Nile virus, vaccinia virus and viral surrogates for relevant and emergent viral pathogens in plasma‐derived products
Identifieur interne : 005844 ( Main/Exploration ); précédent : 005843; suivant : 005845Inactivation of West Nile virus, vaccinia virus and viral surrogates for relevant and emergent viral pathogens in plasma‐derived products
Auteurs : K. M. Remington [États-Unis] ; S. R. Trejo [États-Unis] ; G. Buczynski [États-Unis] ; H. Li [États-Unis] ; W. P. Osheroff [États-Unis] ; J. P. Brown [États-Unis] ; H. Renfrow [États-Unis] ; R. Reynolds [États-Unis] ; D. Y. Pifat [États-Unis]Source :
- Vox Sanguinis [ 0042-9007 ] ; 2004-07.
English descriptors
- Teeft :
- Aliquot, Apptec laboratory services, Biologics evaluation, Blackwell publishing, Blood products, Bvdv, Caprylate, Caprylate concentration, Caprylate treatment, Cholate, Complete inactivation, Diarrhoea virus, Effective inactivation, Encephalitis virus, Gamunex, Hpps, Immunoglobulin, Inactivation, Incubation, Incubation temperature, Infectious virus, Initial virus concentration, Intravenous, Intravenous immunoglobulin, Lower limit, Many years, Model viruses, Nile, Pasteurization, Pathogen, Production scale, Protein concentration, Reduction factor, Robust inactivation, Sanguinis, Sindbis, Sindbis virus, Single determination, Smallpox vaccine, Sodium caprylate, Spiked, Stock solution, Tissue culture, Tnbp, Total inactivation, Tween, Vaccine, Vaccinia, Vaccinia virus, Viral, Viral safety, Virus, Virus inactivation, West nile virus, Whole blood, Wide variety.
Abstract
Background and Objectives Human plasma is the source of a wide variety of therapeutic proteins, yet it is also a potential source of viral contamination. Recent outbreaks of emergent viral pathogens, such as West Nile virus, and the use of live vaccinia virus as a vaccine have prompted a reassessment of the viral safety of plasma‐derived products. The purpose of this study was to evaluate the efficacy of current viral inactivation methods for West Nile and vaccinia viruses and to reassess the use of model viruses to predict inactivation of similar viral pathogens. Materials and Methods Virus‐spiked product intermediates were processed using a downscaled representation of various manufacturing procedures. Virus infectivity was measured before and after processing to determine virus inactivation. Results The results demonstrated effective inactivation of West Nile virus, vaccinia virus and a model virus, bovine viral diarrhoea virus, during pasteurization, solvent/detergent treatment and caprylate treatment. Caprylate provided rapid and effective inactivation of West Nile virus, vaccinia virus, duck hepatitis B virus and Sindbis virus. Inactivation of West Nile virus was similar to that of bovine viral diarrhoea virus. Conclusions This study demonstrates that procedures used to inactivate enveloped viruses in manufacturing processes can achieve inactivation of West Nile virus and vaccinia virus. In addition, the data support the use of model viruses to predict the inactivation of similar emergent viral pathogens.
Url:
DOI: 10.1111/j.1423-0410.2004.00530.x
Affiliations:
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Osheroff</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Preclinical Research and Pathogen Safety, Biological Products Division, Bayer Health Care, LLC, Research Triangle Park, NC</wicri:regionArea><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author><author><name sortKey="Brown, J P" sort="Brown, J P" uniqKey="Brown J" first="J. P." last="Brown">J. P. Brown</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Preclinical Research and Pathogen Safety, Biological Products Division, Bayer Health Care, LLC, Research Triangle Park, NC</wicri:regionArea><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author><author><name sortKey="Renfrow, H" sort="Renfrow, H" uniqKey="Renfrow H" first="H." last="Renfrow">H. 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Pifat</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Preclinical Research and Pathogen Safety, Biological Products Division, Bayer Health Care, LLC, Research Triangle Park, NC</wicri:regionArea><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Vox Sanguinis</title><title level="j" type="alt">VOX SANGUINIS</title><idno type="ISSN">0042-9007</idno><idno type="eISSN">1423-0410</idno><imprint><biblScope unit="vol">87</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="10">10</biblScope><biblScope unit="page" to="18">18</biblScope><biblScope unit="page-count">9</biblScope><publisher>Blackwell Science Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2004-07">2004-07</date></imprint><idno type="ISSN">0042-9007</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0042-9007</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Aliquot</term><term>Apptec laboratory services</term><term>Biologics evaluation</term><term>Blackwell publishing</term><term>Blood products</term><term>Bvdv</term><term>Caprylate</term><term>Caprylate concentration</term><term>Caprylate treatment</term><term>Cholate</term><term>Complete inactivation</term><term>Diarrhoea virus</term><term>Effective inactivation</term><term>Encephalitis virus</term><term>Gamunex</term><term>Hpps</term><term>Immunoglobulin</term><term>Inactivation</term><term>Incubation</term><term>Incubation temperature</term><term>Infectious virus</term><term>Initial virus concentration</term><term>Intravenous</term><term>Intravenous immunoglobulin</term><term>Lower limit</term><term>Many years</term><term>Model viruses</term><term>Nile</term><term>Pasteurization</term><term>Pathogen</term><term>Production scale</term><term>Protein concentration</term><term>Reduction factor</term><term>Robust inactivation</term><term>Sanguinis</term><term>Sindbis</term><term>Sindbis virus</term><term>Single determination</term><term>Smallpox vaccine</term><term>Sodium caprylate</term><term>Spiked</term><term>Stock solution</term><term>Tissue culture</term><term>Tnbp</term><term>Total inactivation</term><term>Tween</term><term>Vaccine</term><term>Vaccinia</term><term>Vaccinia virus</term><term>Viral</term><term>Viral safety</term><term>Virus</term><term>Virus inactivation</term><term>West nile virus</term><term>Whole blood</term><term>Wide variety</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background and Objectives Human plasma is the source of a wide variety of therapeutic proteins, yet it is also a potential source of viral contamination. Recent outbreaks of emergent viral pathogens, such as West Nile virus, and the use of live vaccinia virus as a vaccine have prompted a reassessment of the viral safety of plasma‐derived products. The purpose of this study was to evaluate the efficacy of current viral inactivation methods for West Nile and vaccinia viruses and to reassess the use of model viruses to predict inactivation of similar viral pathogens. Materials and Methods Virus‐spiked product intermediates were processed using a downscaled representation of various manufacturing procedures. Virus infectivity was measured before and after processing to determine virus inactivation. Results The results demonstrated effective inactivation of West Nile virus, vaccinia virus and a model virus, bovine viral diarrhoea virus, during pasteurization, solvent/detergent treatment and caprylate treatment. Caprylate provided rapid and effective inactivation of West Nile virus, vaccinia virus, duck hepatitis B virus and Sindbis virus. Inactivation of West Nile virus was similar to that of bovine viral diarrhoea virus. Conclusions This study demonstrates that procedures used to inactivate enveloped viruses in manufacturing processes can achieve inactivation of West Nile virus and vaccinia virus. In addition, the data support the use of model viruses to predict the inactivation of similar emergent viral pathogens.</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="Remington, K M" sort="Remington, K M" uniqKey="Remington K" first="K. M." last="Remington">K. M. Remington</name></region><name sortKey="Brown, J P" sort="Brown, J P" uniqKey="Brown J" first="J. P." last="Brown">J. P. Brown</name><name sortKey="Buczynski, G" sort="Buczynski, G" uniqKey="Buczynski G" first="G." last="Buczynski">G. Buczynski</name><name sortKey="Li, H" sort="Li, H" uniqKey="Li H" first="H." last="Li">H. Li</name><name sortKey="Osheroff, W P" sort="Osheroff, W P" uniqKey="Osheroff W" first="W. P." last="Osheroff">W. P. Osheroff</name><name sortKey="Pifat, D Y" sort="Pifat, D Y" uniqKey="Pifat D" first="D. Y." last="Pifat">D. Y. Pifat</name><name sortKey="Renfrow, H" sort="Renfrow, H" uniqKey="Renfrow H" first="H." last="Renfrow">H. Renfrow</name><name sortKey="Reynolds, R" sort="Reynolds, R" uniqKey="Reynolds R" first="R." last="Reynolds">R. Reynolds</name><name sortKey="Trejo, S R" sort="Trejo, S R" uniqKey="Trejo S" first="S. R." last="Trejo">S. R. Trejo</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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