Document Detail


Pathogen safety profile of a 10% IgG preparation manufactured using a depth filtration-modified process.
MedLine Citation:
PMID:  22579294     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
Deborah Barnette; Nathan J Roth; Joann Hotta; Kang Cai; Michelle Gall; Randy Hartwell; Jonathan D Kent; Todd Willis
Related Documents :
21302934 - Physical characterization of icosahedral virus ultra structure, stability, and integrit...
21245924 - Comparative production analysis of three phlebovirus nucleoproteins under denaturing or...
4959974 - Studies on the mechanism of action of riley virus. iv. the reticuloendothelial system a...
21247624 - Detection of bovine herpesvirus 1 and 5 in semen from brazilian bulls.
1645594 - Detection of bluetongue virus rna by in situ hybridization: comparison with virus isola...
18825714 - Extrahepatic hepatitis c virus after transplantation: diabetes and renal dysfunction.
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-5-9
Journal Detail:
Title:  Biologicals : journal of the International Association of Biological Standardization     Volume:  -     ISSN:  1095-8320     ISO Abbreviation:  -     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-5-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9004494     Medline TA:  Biologicals     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.
Affiliation:
Grifols Therapeutics Inc, 79 TW Alexander Drive, Research Triangle Park, NC 27709, USA.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Soft matter approaches to food structuring.
Next Document:  HEV infection in swine from Eastern Brazilian Amazon: Evidence of co-infection by different subtypes...