Process for producing Factor VIII having an improved ratio of FVIII: C / FVIII: Ag

摘要

A method for producing, using chromatography, a Factor VIII product, wherein the ratio of FVIII: C / FVIII: Ag in the Factor VIII product is 0.7 or more, wherein at least one chromatography step comprises An affinity chromatography resin having an affinity that specifically binds to factor VIII by an affinity ligand immobilized on the affinity chromatography resin, wherein the affinity ligand is VIII Said method, carried out by using an affinity chromatography resin, an anion chromatography resin, a size exclusion resin, which is a 13 kD yeast-derived Fab antibody fragment against the factor molecule. Factor VIII product obtained by said method for treating hemophilia and for avoiding the formation of inhibitors, having a monomer content of 98% or more.