Biotechnology and the plasma fractionation industry--the impact of advances in the production of coagulation factor VIII.

Several excellent reviews have described the role of biotechnological procedures in the production of pharmaceuticals derived from human blood plasma (Meulien and Tuddenham 1990, Brodniewicz-Proba 1991). The system of blood collection and fractionation is driven by the need to manufacture concentrates of coagulation Factor VIII. This review will analyse the effect of biotechnology on the manufacture of this product. The recent advances in Factor VIII purification using novel immunoaffinity and ion-exchange procedures will be described, as will the technology of the production of recombinant Factor VIII. The impact of these technologies on the manufacture of other therapeutic blood fractions as well as on the whole blood industry will be discussed.