[HIV safety of commercially produced human plasma proteins]

An important aim of the commercial manufacturing of human plasma proteins to be used as therapeutics is the HIV-safety of such products. This aim will be achieved by using (1) plasma donations of carefully selected, healthy donors, (2) by testing of each donation according to national and international requirements for antibodies or antigens specific for certain viruses, (3) by eliminating viruses by different purification procedures of the manufacturing process and (4) by inactivating viruses by a specific method included in the production process. Due to the current discussion in Germany this paper will particularly focus on HIV. As an example, the experimental studies of the manufacturing process of pasteurized factor VIII proving the elimination of HIV by various stages of the production process and its complete inactivation by pasteurization (= 10 h heat treatment of the stabilized, aqueous factor VIII-solution at 60 degrees C) is discussed. A cumulative reduction factor of > 10(16) is achieved by the different stages of the entire manufacturing process, including pasteurization. In fact, the HIV-inactivation is by some orders of magnitude higher than demonstrated by the special inactivation experiment, because the heat treatment of the production procedure consists of 10 hours instead of one hour as needed under experimental conditions for the complete inactivation of HIV. If the manufacturing procedure of a human plasma protein contains a method which completely inactivates HIV and which in total results in a cumulative reduction factor of > 10(12) for HIV, the final product is regarded as being free of infectious HIV.