A PROCESS FOR PREPARATION OF FACTOR IX FROM BIOLOGICAL SOURCES AND FACTOR IX, OBTAINED THEREAFTER

摘要

1. A process for the preparation of factor IX from biological sources by chromatography, characterized in that prior to separation using affinity chromatography said source is treated with ammonium sulfate in a concentration of from 1.5 to 2.3 mol/1. 2. The process according to Claim 1, wherein said biological source is blood plasma or plasma depleted of factor VIII and fibrinogen by separation of the cryoprecipitate (cryopoor plasma). 3. The process according to one of Claims 1 or 2, wherein removal of the protein precipitant and enrichment of factor IX by adsorption of factor IX to a chromato-graphic material capable of being employed for hydrophobic interaction chromatography (HIC) are performed following protein precipitation. 4. The process according to Claim 3, wherein said chromato-graphic material having adsorbed factor IX is treated with an aqueous solution having an ionic strength resulting in separation of factor IX from said HIC material. 5. The process according to Claim 3 and/or 4, wherein the fractions obtained after separation of factor IX from said HIC material are subjected to a process step which reduces the salt concentration of the solution containing factor IX, e.g. by ultrafiltration/diafiltration. 6. The process according to Claim 5, which is followed by affinity chromatography on a heparin modified substrate material. 7. The process according to any of Claims 1 to 6, wherein virus inactivation is performed by chemical and/or physical means. 8. The process according to Claim 7, wherein said physical virus inactivation comprises heat treatment at 60 to 65 degree C for 5 to 30 hours, in particular following said affinity chromatography on heparin according to Claim 6. 9. The process according to Claim 7, wherein said chemical virus inactivation comprises treatment of the sample containing factor IX with non-ionic detergents/dialkylated or trialkylated phosphates. 10. Factor IX obtained by the process according to at least one of preceding Claims. Eurasian patent is valid in all Contracting states except for AM and MD.