New methods for inactivation of lipid‐enveloped and nonenveloped viruses

Summary. Two new methods are described for inactivating lipid-enveloped and non-enveloped viruses in plasma-derived products such as coagulation factors and intravenous immunoglobulin (IGIV). Iodine/Sephadex® delivers iodine to IGIV solutions in a slow, controlled way and allows for inactivation of ≥4 logs of porcine parvovirus (PPV), a hardy non-enveloped virus, under conditions which do not measurably damage the structural or functional properties of the IGIV, and with essentially no iodination of the protein. All detectable enveloped and non-enveloped viruses were inactivated by this treatment. Gamma irradiation has been successfully used to inactivate viruses at the final vial stage in freezedried plasma proteins. Four logs of PPV were inactivated by irradiation in the presence of fibrinogen, factor VIII and α1-proteinase inhibitor (API) at doses of 23, 28 and 30 kiloGray (kGy) respectively, while retaining 93% of fibrinogen solubility, 67% of factor VIII activity and over 80% of API activity. Bovine viral diarrhea virus (BVDV), a lipid-enveloped model for hepatitis C virus, was completely inactivated by radiation doses of 20–30 kGy in these products. Gamma irradiation was less effective in inactivating viruses in freeze-dried IGIV.