Method for manufacturing high purified factor ix product
2005
A purification method of a high purified blood clotting factor IX is provided to improve specific activity of the blood clotting factor IX by removing impure proteins from the blood clotting factor IX through a series of purification procedures. The purification method of a high purified blood clotting factor IX comprises the steps of: subjecting cryopaste-free human serum to anion exchange chromatography; treating the active fraction of the anion exchange chromatography with solvent/detergent(S/D) so as to inactivate viruses; subjecting the S/D treatment product to anion exchange chromatography; subjecting the active fraction of the anion exchange chromatography to heparin affinity chromatography; subjecting the active fraction of the heparin affinity chromatography to cation exchange chromatography; and subjecting the active fraction of the cation exchange chromatography to nanofiltration so as to remove viruses.
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KQI