Gamma irradiation of intravenous immunoglobulin

This paper describes gamma irradiation of a biotherapeutic product under conditions (the Clearant Process") that protect proteins and foster inactivation of viruses and other pathogens. The treated product was immunoglobulin paste from cold ethanol fractionation of human plasma, a process intermediate in the production of intravenous immunoglobulin (IGIV). The frozen paste was irradiated on dry ice to 45 kGy, conditions that inactivate > or = 4 log10 of non-enveloped viruses and > or = 6 log10 of enveloped viruses. When IGIV purified from the irradiated paste was characterized, no protein aggregation, fragmentation, oxidation or denaturation was detected and Fab functionality remained intact.