Preparation of Stable Intermediate-Purity Factor VIII Concentrate with a Note on High-Purity Factor VIII

Abstract

Cryoprecipitate prepared by a rapid thawing technique was pooled in batches of 600-720 donor units and washed with ice-cold Tris-citrate-NaCl solution. After dissolving at 37 °C, it was adsorbed with Al(OH)(3) and kaolin, and cleared by centrifugation. The supernatant, diluted with 5% dextrose was passed repeatedly through a bed of Celite, filtered through a 293 mm X 0.3 μm membrane disc and lyophilized. Typical composition was 15 U · ml^-1 factor VIII, and 40 mg · ml^-1 protein with a yield of 300 U/l of starting plasma. The crude factor VIII concentrate was also a suitable material for preparation of high-purity factor VIII by controlled pore glass chromatography.