Inactivation of the human immunodeficiency viruses (HIV-1 and HIV-2) during the manufacturing of placental albumin and gammaglobulins.

A laboratory study was undertaken to verify the elimination and/or inactivation of the human immunodeficiency viruses HIV-1 and HIV-2 during the manufacture of placental albumin and the gammaglobulins Gamma 16 and Veinoglobuline. Nine steps of the process were selected for study. Samples of current production batches were taken at these different stages and a known quantity of virus was added. Each sample was then processed according to the production schedule for the corresponding step, and the residual viral activity was measured. In eight of nine steps, a complete viral clearance was achieved. Estimation of the cumulative infectivity reduction due to these nine steps is in the following range: greater than 12 to 16 log10 HIV-1 and greater than 17 to 19 log10 HIV-2 for Gamma 16, greater than 9 to 13 log10 HIV-1 and greater than 13 to 15 log10 HIV-2 for Veinoglobuline, and greater than 19.7 log10 HIV-1 and greater than 24 log10 HIV-2 for albumin. As many other purification steps were not included in this study, the real infectivity reduction capacity for the whole process probably exceeds these values. Nevertheless, the levels of inactivation measured clearly document a rigorous fractionation process that has a high assurance of killing or eliminating all contaminating virus.