Human intravenous immunoglobulin preparation and virus inactivation by pasteurization and solvent detergent treatment

Human intravenous immunoglobulin (IVIG) solutions were prepared by two diff erent methods and compared to each other. The crude immunoglobulin fraction obtained from Cohn-Oncley fractionation of plasma was further purified and subjected to virus inactivation, either by polyethylene glycol precipitati on and pasteurization at 60 degrees C for 10 hours, or by ion exchange chro matography and solvent/detergent treatment. The final preparations, formulated in 5% immunoglobulin solutions were char acterized by in vitro analyses of biochemical and biological properties and compared with the samples of other manufacturer's IVIG solution products. The critical properties evaluated in this study were purity, molecular inta ctness, and the biological functions such as Pc function and anticomplement ary activity. Virus inactivation and removal by processing steps and by deliberate viruci dal steps, as described above, were tested on various human pathogenic viru ses, such as human immunodeficiency and experimental model viruses. The tes ted viruses were successfully inactivated and removed. We conclude that the intravenous immunoglobulins prepared by two different methods, as describe d above, provide an equivalent viral safety and quality.