Importance

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Abstract

This disclosure pertains to a concentrate for controlling bleeding in hemophilia, free of thrombin, heparin, thromboplastin activity, anticomplement activity, depressor activity, and activated Factor X, and containing coagulation Factors II, VII, IX, and X in non-activated form and containing no greater amounts of calcium-activated factors and Factor VIII Inhibitor Bypassing Activity substance than that found in concentrates of Factor II, VII, IX, and XI that have not been treated, respectively, with calcium or a material which would produce a Factor VIII Inhibitor Bypassing Activity substance in such concentrates and having a specific activity of at least about 1.5 Factor IX units per milligram of total protein and a Factor IX:Factor VII ratio of at least about 6:1, a Factor IX:Factor II ratio of about 1:1 to 2:1, and a Factor IX:NAPTT ratio of at least about 5:1 on a Units per milliliter basis, a Factor II Specific Activity of about 1.0-4.0 Units per milligram of total protein, and a Factor IX:ceruloplasmin ratio of at least about 25:1. In the method of the invention a blood fraction containing coagulation Factors II, VII, IX, and X is applied to an anion exchanger to adsorb the coagulation Factors, which are selectively eluted therefrom using an aqueous sodium chloride-citrate solution of increasing ionic strength. The eluate is treated to reduce its concentration of non-volatile salt and concentrated to yield the above product.

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First Claim