Controlled pore glass factor VIII concentrate: influence of heat treatment.

A high purity factor VIII concentrate prepared by controlled pore glass (CPG) adsorption chromatography was stabilized with an amino acid mixture, lyophilized and heat treated at 60 degrees C for 72 h. Heat treatment of the freeze-dried concentrate resulted in less than 10% further loss of factor VIII activity, with a final yield of factor VIII from starting plasma of 25%. Heat treatment did not alter product reconstitution, nor appearance, and clinical experience has been favourable. Following infusion into 9 hemophiliac patients the mean ex vivo recovery (1.03) was not significantly different from that obtained with the non-heated CPG concentrate. The mean half lives (T1/2) of both heated and non-heat treated material were identical. Stabilization and heat treatment of CPG does not influence the excellent ex vivo recovery, nor therapeutic response, and is not associated with other adverse side effects.