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 freeze-dried 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.
CITATION STYLE
Miekka, S. I., Busby, T. F., Reid, B., Pollock, R., Ralston, A., & Drohan, W. N. (1998). New methods for inactivation of lipid-enveloped and non-enveloped viruses. In Haemophilia (Vol. 4, pp. 402–408). Blackwell Publishing Ltd. https://doi.org/10.1046/j.1365-2516.1998.440402.x
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