PROCESS FOR THE PURIFICATION OF FACTOR VII POLYPEPTIDES USING AFFINITY RESINS COMPRISING SPECIFIC LIGANDS

摘要

The invention concerns a process for the purification of a drug substance of a Factor VII polypeptide, said process comprising the steps of: (a) contacting the drug substance with an affinity resin under conditions which facilitate binding of a portion of said drug substance to said affinity resin; (b) optionally washing said affinity resin containing bound drug substance with a washing buffer; and (c) eluting said affinity resin containing bound drug substance with an elution buffer, and collecting a purified drug substance of the Factor VII polypeptide as an eluate; wherein said affinity resin is a solid phase material having covalently immobilized thereto one or more ligands of the general formula (I), wherein each of R1, R2 and R3 represents an organic moiety of a molecular weight of 15-1000 g/mol, the total molecular weight of said ligand being 200- 2000 g/mol; said ligand being immobilized to said solid phase material via one of said organic moieties R1, R2 and R3.