| 摘要 |
PROBLEM TO BE SOLVED: To provide a purification method by removal of product-related impurities in industrial-scale in a drug substance of a Factor VII polypeptide.SOLUTION: The present invention provides a purification method in a drug substance of a recombinantly-made Factor VII polypeptide comprising: (a) contacting the drug substance with a hydrophobic interaction chromatography material under conditions which facilitate binding of a portion of the drug substance to the hydrophobic interaction chromatography material, the drug substance comprising salts and/or a zwitterion in a concentration of in the range of 0.0-0.1 M or in the range of 0.5 M to 85% of the saturation concentration for the respective salt; (b) optionally washing the hydrophobic interaction chromatography material with a washing buffer; and (c) eluting the hydrophobic interaction chromatography material with an elution buffer, and collecting a purified drug substance of the Factor VII polypeptide as an eluate. |
