title: Inactivation of hepatitis C virus in low pH intravenous immunoglobulin.
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.
authors.affiliation: Miles, Inc., Pharmaceutical Division, Berkeley, California 94701.
authors.forename: R E
authors.initials: RE
authors.lastname: Louie
authors.forename: C J
authors.initials: CJ
authors.lastname: Galloway
authors.forename: M L
authors.initials: ML
authors.lastname: Dumas
authors.forename: M F
authors.initials: MF
authors.lastname: Wong
authors.forename: G
authors.initials: G
authors.lastname: Mitra
mesh_terms: D000818:Animals; D001483:Base Sequence; D003080:Cold Temperature; D017931:DNA Primers; D001908:Diarrhea Viruses, Bovine Viral / Q000302:isolation & purification; D000431:Ethanol; D016174:Hepacivirus / Q000302:isolation & purification; D006863:Hydrogen-Ion Concentration; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage; D007262:Infusions, Intravenous; D008969:Molecular Sequence Data; D002679:Pan troglodytes; D016133:Polymerase Chain Reaction; D010948:Viral Plaque Assay
chemical_list: D017931:DNA Primers; D016756:Immunoglobulins, Intravenous; D000431:Ethanol