Factor VIII concentrate from cold sterilized human plasma.

beta-Propiolactone (beta-PL) in combination with UV irradiation (UV) is an established method for the sterilization of factor IX concentrate or stabilized human serum. Because of the extreme sensitivity of factor VIII to beta-PL, the standard beta-PL/UV procedure cannot be used to obtain hepatitis-safe factor VIII concentrate. It has been shown in chimpanzees that from a cryoprecipitate containing hepatitis non-A, non-B viruses in addition to hepatitis B viruses a factor VIII concentrate (160 U/10 ml) can be prepared by a modified beta-PL/UV procedure, which induces neither hepatitis B nor hepatitis non-A, non-B in experimental animals; the non-sterilized original cryoprecipitate proved to be infectious.