Inactivation of hepatitis C virus in low pH intravenous immunoglobulin.

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.