Process for the manufacture of a high-purity activated factor VII concentrate essentially free of vitamin K-dependent factors and factors VIIIC and VIIICAg

Abstract

The invention relates to a process for the manufacture of a high-purity activated factor VII concentrate. This process comprises the use of a plasma free of cryoprecipitate, preferably of human origin, as well as at least one purification step involving chromatography at least once on an ion exchange resin, and a factor VII activation step, wherein the first stage is direct activation of the factor VII in the crude supernatant of plasma free of cryoprecipitate, without the addition of exogenous proteins. By virtue of the invention, the high-purity activated factor VII is essentially free of vitamin K-dependent factors and factors VIIIC and VIIICAg and has a factor VIIa/factor VII ratio greater than 5 with a specific activity of the activated factor VII greater than 200 IU/mg of proteins.

Dependencies are inferred from the claim text.