Pilot scale (300 kg) fractionation of plasma for factor VIII and factor IX

Abstract

Pilot-scale processing of plasma to factor VIII and factor IX concentrates has been used to provide advance information for manufacturing at >3000 kg scale, and to confirm or extend data obtained by model (3 kg) fractionation experiments. It has been applied especially to the validation of apheresed plasma procured by various semi-automated procedures and in different anticoagulants. There are inter-Regional differences in the quality of plasma as measured by the recovery of factor VIII in the cryoprecipitate, but stage yields on further processing are constant. The low concentration of citrate in ACD-B plasma leads to insecure anticoagulation during the early stages of processing, and such plasma is not acceptable for the routine production of factor IX concentrate. The sequence in which other clinically useful proteins are removed from plasma influences the quality of factor IX concentrate, as measured by in vitro tests for activated factors.