The transmission of pathogenic agents by transfusion of cellular and protein products derived from blood is an ongoing and serious problem. The proposed studies are designed to evaluate both physical and chemical approaches for the inactivation of viruses in these products. Process methods will be selected initially on the basis of sterilization efficacy against easily quantifiable viruses, and of recovery of intact and functioning red cells, platelets, and plasma coagulation factors. After promising approaches have been identified, their efficiency in inactivating HIV and type B and non-A, non-B hepatitis viruses will be evaluated in tissue culture and in chimpanzees, respectively. Finally, demonstration lots of virus sterilized fresh frozen plasma, cryoprecipitate, and units of red blood cell and platelet concentrates will be prepared and evaluated clinically. The New York Blood Center is especially well suited to accomplish these goals because of its extensive research with blood borne viruses, its experience in developing and evaluating methods of virus inactivation applicable to purified protein derivatives, and because of the availability of our primate facility in Liberia. This project will further benefit from our supply of resource material; our laboratory, pilot plant, and components facilities; and our experience in handling and analyzing plasma proteins and blood components and in preparing experimental and licensed biologics for therapeutic use in humans.
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