Inactivation and Elimination of Viruses during the Fractionation of an Intravenous Immunoglobulin Preparation: Liquid Heat Treatment and Polyethylene Glycol Fractionation

Abstract. A method for the heat treatment of human IgG solution at 60 °C for 10 h was established. Human immunodeficiency, mumps, vaccinia and 4 other viruses were added to the IgG solution in 33% sorbitol and heated at 60 °C. Those viruses were inactivated within 1 h. Heat‐treated intravenous IgG (IVIG‐H) was prepared by heat treatment and polyethylene glycol (PEG) fractionation. Conventional nonheated intravenous IgG (IVIG‐C) was prepared from the same source paste by the fractionation method. No physicochemical or biological difference was observed between the heated and control IVIG preparations.