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About:
Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies
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wasabi.inria.fr
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research paper
schema:ScholarlyArticle
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type
Academic Article
research paper
schema:ScholarlyArticle
isDefinedBy
Covid-on-the-Web dataset
has title
Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies
Creator
Kempf, Christoph
Gröner, Albrecht
Kreil, Thomas
Pifat, Dominique
Gajardo, Rodrigo
Biesert, Lothar
Dichtelmüller, Herbert
Fabbrizzi, Fabrizio
Jorquera, Juan
Osheroff, Wendy
Poelsler, Gerhard
Von Hoegen, Ilka
Source
PMC
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.
has issue date
2009-05-20
(
xsd:dateTime
)
bibo:doi
10.1111/j.1537-2995.2009.02222.x
has license
no-cc
sha1sum (hex)
7590f2f9c49cd344821b62e2c1472dd23537c35e
schema:url
https://doi.org/10.1111/j.1537-2995.2009.02222.x
resource representing a document's title
Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies
has PubMed Central identifier
PMC7187780
schema:publication
Transfusion
resource representing a document's body
covid:7590f2f9c49cd344821b62e2c1472dd23537c35e#body_text
is
schema:about
of
named entity 'detergent'
named entity 'solvent'
named entity 'Plasma'
named entity 'data collection'
named entity 'Protein'
named entity 'cell culture'
named entity 'detergent'
named entity 'cell cultures'
named entity 'pH 4'
named entity '60 minutes'
named entity 'IVIG'
named entity 'virus'
named entity 'HBV'
named entity 'HCV'
named entity 'virus'
named entity 'vesicular stomatitis virus'
named entity 'hepatitis C virus'
named entity 'arthritis'
named entity 'virus'
named entity 'protein'
named entity 'medicinal products'
named entity 'enveloped viruses'
named entity '2.0'
named entity 'BVDV'
named entity 'virus'
named entity 'protein'
named entity 'protein'
named entity 'virus'
named entity 'PRV'
named entity 'Triton X-100'
named entity 'detergent'
named entity 'virus'
named entity 'pH 8'
named entity 'virus'
named entity 'detergent'
named entity '7.5'
named entity 'infectivity'
named entity 'IVIG'
named entity 'virus'
named entity 'virus'
named entity 'protein'
named entity 'virus'
named entity 'virus'
named entity 'virus'
named entity 'infectivity'
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named entity 'IMIG'
named entity 'viruses'
named entity 'Tween 80'
named entity 'Tween 80'
named entity 'detergent'
named entity 'virus'
named entity 'detergents'
named entity 'heat treatment'
named entity 'viruses'
named entity 'Triton X-100'
named entity 'process variables'
named entity 'incubation time'
named entity 'IVIG'
named entity 'HCV'
named entity 'HBV'
named entity 'virus'
named entity 'protein'
named entity 'virus'
named entity 'VSV'
named entity 'virus'
named entity 'solvent'
named entity 'virus'
named entity 'cholate'
named entity 'virus'
named entity 'enveloped viruses'
named entity 'virus'
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