[Viral validation of the bio-globulin production process]

Intravenous human immunoglobulin of domestic production was subjected to validation studies. Tests were performed in the system of model viruses for pathogenic factors of the B and C types of hepatitis. For simulated immunoglobulin infections two lipid-enveloped viruses were chosen: the first DNA virus pseudorabies PR-75 (model for HBV) and the second-RNA virus Sindbis (model for HCV). The survival of viruses in particular stages of bio-globulin production was checked, showing that pepsin digestion led to full inactivation of both viruses. The total reduction of infective titers of model viruses during the whole process exceeded 10 logs. Thus we can conclude that the process of bio-globulin manufacturing ensures the elimination and inactivation of lipid-enveloped viruses.