Purification of factor IX

Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues – Blood proteins or globulins – e.g. – proteoglycans – platelet...

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530384, 530413, 530417, 530420, 530427, A61K 3516, A61K 3702, C07K 320

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active

052868494

ABSTRACT:
The present invention relates to a process for purifying Factor IX from an impure protein fraction containing Factor IX. The purification process comprises the steps of adding a solvent and a detergent to an impure protein fraction and incubating the solvent/detergent protein solution to inactivate any viral contaminants. Factor IX is purified from the solvent/detergent protein solution by chromatography on a sulfated polysaccharide resin without first removing the solvent and detergent prior to the purification on the sulfated polysaccharide resin. The Factor IX, purified by the process has a specific activity of at least 85 units/mg.

REFERENCES:
patent: 4725673 (1988-01-01), Herring
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Ahmad et al., "Rapid Purification of Factor IX, Factor X and Prothrombin by Immunoaffinity and Ion Exchange Chromatography, "Thromb. Res., 55, 121-133 (1989).
Tharakan et al., "Development of an Immunoaffinity Process for Factor IX Purification," Vox Sang, 58, 21-29 (1990).
Hrinda et al., "Preclinical Studies of a Monoclonal Antibody-Purified Factor IX, Mononine.sup..TM.," Sem. in Hematol., 28, 6-14 (1991).
Kim et al., "Purified Factor IX Using Monoclonal Immunoaffinity Technique: Clinical Trials in Hemophilia B and Comparison to Prothrombin Complex Concentrates," Blood, 79, 568-575 (1992).
Bajaj et al., "A Simplified Procedure for Purification of Human Prothrombin, Factor IX and Factor X," Prep. Biochem., 11, 397-412 (1981).
Andersson et al., "Purification and Characterization of Human Factor IX," Thromb. Res., 7, 451-459 (1975).
Menache et al., "Coagulation Factor IX Concentrate: Method of Preparation and Assessment of Potential In Vivo Thrombogenicity in Animal Models," Blood, 64, 1220-1227 (1984).
T. Brodniewicz-Proba, "Human Plasma Fractionation and the Impact of New Technologies on the Use and Quality of Plasma-derived Products," Blood Reviews, 5, 245-257 (1991).

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