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It has been known that albumin and plasma protein fraction (PPF) do not transmit hepatitis since these products are heated at 60°C for 10 hours. This heating is sufficient for inactivation of hepatitis virus. It has been previously tried to heat the Cohn Fractions leading to Factor VIII and Factor IX Concentrates in solution, however, this has resulted in significant loss of Factors VIII and IX.  We have taken lyophilized Factor VIII Concentrate powder and heated it in a waterbath at 60°C for 10 hours and have demonstrated no significant change in in vitro recovery of Factor VIII activity four hours following the heating. The same was shown for recovery of Factor IX activity after heating lyophilized Factor IX concentrate for 10 hours at 60°C. In addition Factor IX activity was not destroyed following heating of the lyophilized powder for 20-30 minutes at 100°C. This is significant because now potentially this heated lyophilized powder of Factor VIII and Factor IX is free of previous risk of transmission of hepatitis. However, the effect of heating on the thrombogenic effects in vivo of the concentrates and complications was not assessed in this study. Chimpanzee studies are planned to determine whether the heating has inactivated the hepatitis virus.  It is possible that a longer heating time will be needed to sufficiently inactivate the hepatitis virus in the lyophilized state.

Heated Lyophilized Factor VIII And Factor IX Concentrate Preliminary In Vitro Studies