THERAPEUTIC PREPARATION OF VERY HIGH PURITY FVIIa AND METHOD FOR OBTAINING SAME

Abstract

The therapeutic preparation of FVIIa having a purity of at least 1000 IU/mg of protein is characterized in that said preparation is free of proteins of non-human origin. In the method for obtaining FVII, purification starts from FrII+III, FrIII or equivalent of Cohn fractioning and comprises precipitation with PEG, chromatography and its subsequent activation.

Description

Claims

1. A therapeutic preparation of FVIIa having a purity of at least 1000 IU/mg of protein, wherein said preparation is free of proteins of non-human origin.

2. A therapeutic preparation of FVIIa, according to claim 1, wherein its purity is at least 6000 IU/mg of protein.

3. A therapeutic preparation of FVIIa according to claim 2, wherein the FVIIa is present at a concentration of at least 12000 IU/ml.

4. A therapeutic preparation of FVIIa according to claim 1, wherein the FVIIa comes from human plasma.

5. A therapeutic preparation of FVIIa according to claim 4, wherein it has been subjected to at least one stage of elimination of pathogenic agents.

6. A method for obtaining a therapeutic preparation of FVIIa, according to claim 1, wherein the FVII is purified starting from FrII+III, FrIII or equivalent of Cohn fractioning and comprises precipitation with PEG, chromatography and its activation.

7. A method for obtaining a therapeutic preparation of FVIIa according to claim 6, wherein the suspension of FrII+III, FrIII or equivalent is precipitated at a concentration of between 3 and 7% of PEG.

8. A method for obtaining a therapeutic preparation of FVIIa according to claim 6, wherein the FVII is captured by ion exchange chromatography.

9. A method for obtaining a therapeutic preparation of FVIIa according to claim 6, wherein the chromatographic elution is carried out by change of pH.

10. A method for obtaining a therapeutic preparation of FVIIa, according to claim 6, wherein the FVII is purified by hydrophobic interaction chromatography.

11. A method for obtaining a therapeutic preparation of FVIIa according to claim 6, wherein the procedure is carried out in the absence of ammonium salts.

12. A method for obtaining a therapeutic preparation of FVIIa according to claim 6, wherein a stage of purification of the FVII is carried out by Metal Chelation Chromatography.

13. A method for obtaining a therapeutic preparation of FVIIa according to claim 12, wherein the metal chelation resin is Ni Sepharose HP.

14. A method for obtaining a therapeutic preparation of FVIIa according to claim 6, wherein the FVII is activated in the presence of calcium.

15. A method for obtaining a therapeutic preparation of FVIIa according to claim 6, wherein it comprises at least one specific stage of virus elimination.

16. A method for obtaining a therapeutic preparation of FVIIa according to claim 15, wherein it comprises a stage of virus elimination by nanofiltration.

17. A method for obtaining a therapeutic preparation of FVIIa according to claim 15, wherein it comprises a stage of virus elimination by treatment with solvent/detergent.