A Factor VII Concentrate for Therapeutic Use

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Abstract
A concentrate of factor VII suitable for therapeutic use was prepared from human plasma by a method forming part of a comprehensive scheme of large-scale plasma fractionation. Factor VIII was separated as cryoprecipitate and factors II, IX and X were adsorbed on DEAE-cellulose. Most of the factor VII remained in the supernatant. By batch adsorption on DEAE-Sepharose, followed by elution on a chromatographic column, factor VII was concentrated about 25-fold and purified about 50-fold compared with original plasma, without the need for further dialysis or concentration steps. Data were presented from 10 batches, each from 80-120 kg plasma. Following doses of factor VII to 6 congenitally deficient patients, the mean rise in plasma factor VII was 95-100% of theoretical; the half-disappearance time was about 4 h. Treatment of 4 patients with acquired deficiency of factor VII was also described. No untoward side effects were observed.