Pasteurization as an efficient method to inactivate blood borne viruses in factor VIII concentrates.

Heat treatment at 60 degrees C for 10 h in solution (pasteurization) was introduced into the manufacturing process of factor VIII concentrate (Haemate P) in order to considerably reduce the risk of transmission of human pathogenic viruses to haemophiliacs. The results of experimental and clinical studies with regard to hepatitis B, non-A, non-B hepatitis, acquired immune deficiency syndrome (AIDS) and herpes virus infections are reviewed. From this data it is concluded that pasteurization of factor VIII results in a product which is safe with regard to these viral infections. Furthermore, it was shown that pasteurization does not form new antigenic determinants on the factor VIII molecule and compared with the native product does not alter the physiological properties of this protein in patients. In comparison to these advantageous properties of the pasteurized product a slight loss of coagulant activity seems to be acceptable. This loss of yield, however, does not influence the quality or the amount of factor VIII in the final container used for the therapy of haemophilia A patients.