Abstract A simple process for large‐scale manufacture of ‘high‐purity’ factor VIII is described in detail. A crude concentrate prepared from washed cryo is treated with controlled pore glass (CPG, 500Å pore diameter) in proportion of 20–30 ml of CPG to 1 g input of protein. The slurry is poured into a separation column and the effluent purified concentrate collected. The remaining factor VIII in the void volume is displaced by a wash solution. After passage through a 0.2 μm membrane filter the product is dispensed and lyophilized. Maintaining the operating pH at 6.5–6.7 and adding synthetic amino acids improved the yield and solubility. The current concentrate contains 1 unit of factor VIII per mg protein (10 units mg fibrinogen) with a recovery of 250 units/kg plasma. The CPG stage is non‐destructive, yielding more than 90% of the input factor VIII. In 1980–1983, more than 3times10 6 units have been used in New South Wales, mostly for massive cover in surgical patients. In collaboration with the Commonwealth Serum Laboratories, it is intended to expand production for use in other Australian States.
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 × 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.
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