A Factor VIII Concentrate of Intermediate Purity and Higher Potency

Abstract
A fractionation method was modified to produce a [human] factor VIII concentrate of intermediate purity and a potency of about 12 IU ml, suitable for injection by syringe. The solubility, ease of filtration and purity of the concentrate were improved by including a stage in which contaminants are precipitated at controlled temperature, pH and ionic strength. A summary of the first 50 production-scale batches was presented. Plasma could be harvested from whole blood and frozen within 8 h of donation, or after overnight storage of whole blood, with no significant difference in overall yield.