HIV SAFETY OF COMMERCIALLY PREPARED HUMAN PLASMA-PROTEINS

An important aim of the commercial manufacturing of human plasma prote ins to be used as therapeutics is the HIV-safety of such products. Thi s aim will be achieved by using (1) plasma donations of carefully sele cted, healthy donors, (2) by testing of each donation according to nat ional and international requirements for antibodies or antigens specif ic for certain viruses, (3) by eliminating viruses by different purifi cation 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 focu s on HIV. As an example, the experimental studies of the manufacturing process of pasteurized factor VIII proving the eliminiation of HIV by various stages of the production process and its complete inactivatio n by pasteurization (= 10 h heat treatment of the stabilized, aqueous factor VIII-solution at 60 degrees C) is discussed. A cumulative reduc tion factor of > 10(16) is achieved by the different stages of the ent ire manufacturing process, including pasteurization. In fact, the HIV- inactivation is by some orders of magnitude higher than demonstrated b y the special inactivation experiment, because the heat treatment of t he production procedure consists of 10 hours instead of one hour as ne eded under experimental conditions for the complete inactivation of HI V, 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.