| Pathogen safety profile of a 10% IgG preparation manufactured using a depth filtration-modified process. | |
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MedLine Citation:
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PMID: 22579294 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Gamunex(®)-C is a highly purified liquid 10% IgG preparation manufactured by a process that includes caprylate precipitation and incubation, and chromatography steps. In the original process, caprylate precipitation was followed by cloth filtration to remove impurities. The highly porous cloth filter has since been replaced with a tight depth filter. The impact of this process modification on pathogen reduction and product is presented. Virus and prion reduction was determined under set-point conditions using scaled-down models of the manufacturing process, and at or outside operating limits to determine robustness. Product protein compositions before and after the process modification were compared directly using manufacturing data. Filtration through a tight depth filter substantially increased nonenveloped virus reduction, and virus reduction was maintained even when a compromised depth filter was used. In addition, prion reduction was improved by about three logs. The product IgG content, purity, and IgG subclass distribution remained comparable to the original cloth filtration process. The replacement of cloth filtration with depth filtration increased the pathogen safety margin of the manufacturing process without impacting the product composition. |
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Authors:
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Deborah Barnette; Nathan J Roth; Joann Hotta; Kang Cai; Michelle Gall; Randy Hartwell; Jonathan D Kent; Todd Willis |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-5-9 |
Journal Detail:
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Title: Biologicals : journal of the International Association of Biological Standardization Volume: - ISSN: 1095-8320 ISO Abbreviation: - Publication Date: 2012 May |
Date Detail:
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Created Date: 2012-5-14 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9004494 Medline TA: Biologicals Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2012 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved. |
Affiliation:
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Grifols Therapeutics Inc, 79 TW Alexander Drive, Research Triangle Park, NC 27709, USA. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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