Manufacturing in the Blood Bank of High Purity Heat-Treated Factor VIII Concentrate from Heparin Stabilized Blood and its Consequences for the Red Cell and Supernate Plasma Components

The blood bank in Aarhus, Denmark, has since 1964 produced a freeze-dried cryoprecipitate in amounts of 1 – 2 × 106 IU factor VIII per year. The factor VIII depleted plasma has also been freeze-dried and used locally in conventional component therapy as an albumin substitute. Freeze-dried cryoprecipitate looses between 50 and 80% of its factor VIII activity by heating to 68°C for 24 h. Due to governmental regulations demanding for heat treatment of factor VIII preparations, we were obliged to discontinue production of cryoprecipitate and turn to the manufacturing of a high purity factor VIII concentrate.