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Inactivation of hepatitis C virus in low pH intravenous immunoglobulin.

作者信息

Louie R E, Galloway C J, Dumas M L, Wong M F, Mitra G

机构信息

Miles, Inc., Pharmaceutical Division, Berkeley, California 94701.

出版信息

Biologicals. 1994 Mar;22(1):13-9. doi: 10.1006/biol.1994.1003.

DOI:10.1006/biol.1994.1003
PMID:8068309
Abstract

The safety from hepatitis C virus of intravenous immunoglobulin prepared by the cold ethanol method of Cohn-Oncley is demonstrated by clearance through the manufacturing process of 9 x 10(6) plaque-forming units of bovine viral diarrhea virus used as a surrogate for hepatitis C virus. Incubation of the intravenous immunoglobulin in its final formulation at pH 4.25 for 21 days at 21 degrees C caused a 10,000-fold decrease in bovine viral diarrhea virus intentionally added and complete inactivation of 1000 chimpanzee infectious doses per ml of hepatitis C virus.

摘要

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