Inactivation of HIV-1 and HIV-2 by various manufacturing procedures for human plasma proteins

Human retroviruses causing AIDS (HIV-1, HIV-2) can occur in human plasma donations. Since HIV-contaminated plasma cannot be completely excluded by testing for anti-HIV-1 (routine plasma screening for anti-HIV-2 has not yet been established), a safeguard against AIDS in therapeutics derived from human plasma can only be achieved by introducing HIV inactivating/eliminating methods into the manufacturing process of plasma derivatives. To investigate the HIV inactivating efficiency of such methods, aliquots of infectious HIV-1 or HIV-2 concentrates were added to a protein preparation, the resulting HIV spiked preparation was then treated according to the method to be studied, and the amount of infectious HIV in this preparation was determined before and after treatment. Methods by which HIV-1 or HIV-2, respectively, were completely inactivated were ethanol fractionation according to the Cohn procedure, pepsin treatment, affinity chromatography, protein precipitation by various methods, and pasteurization (heat treatment at 60 degrees C in aqueous solution). The use of these methods for manufacturing human plasma derivatives resulted in products that were free of any infectious HIV-1 or HIV-2 and thus unable to transmit AIDS.