Small-pool high-yield factor VIII production

Hemophilia care depends on several factors for the production of purified FVIII: plasma procurement, plasma logistics, production method, and efficacy. The latter two are restrictive factors, both for the supply and the safety of FVIII preparations. Conventional production methodology unavoidably recovers only 10 to 20% of usable protein, therefore requiring large pools of source plasma. Related to pool size is the transmission of diseases, which poses unnecessary risks for patients. The development of new technologies to better recover FVIII allows reduction of the pool size: crush-thaw, controlled pore-glass chromatography, and heparin double-cold precipitation techniques. This review will reflect on current production methods, pool size concept, small-pool approaches in FVIII production, and future developments.