Patent ID: 9023992
Filing Date: 2015-05-05
Classification: A61P,C07K

Abstract:
1. A process for reducing the content of forms of activated Factor VII lacking one or more N-linked glycan(s) in a drug substance of a recombinantly made activated Factor VII polypeptide, said process comprising the steps of: (a) contacting the drug substance with a hydrophobic interaction chromatography material comprising a butyl ligand and/or phenyl ligand under conditions which facilitate binding of a portion of said drug substance to said hydrophobic interaction chromatography material, said drug substance further comprising a salt selected from: ammonium acetate, ammonium sulphate, ammonium chloride, sodium chloride, sodium acetate, sodium sulphate, potassium acetate, potassium chloride, and potassium sulphate, and/or a zwitterion selected from: glycine, alanine, beta-alanine, leucine, and isoleucine, in a concentration of about 0.0 to 0.1 M in the range of from 0.5 M to 85% of the saturation concentration for the respective salt at the temperature at which step (a) is carried out; (b) optionally washing said hydrophobic interaction chromatography material with a washing buffer; and (c) eluting said hydrophobic interaction chromatography material with an elution buffer, and collecting a purified drug substance of the activated Factor VII polypeptide as an eluate; wherein the content of forms of activated Factor VII polypeptide lacking one or more N-linked glycan(s) in the purified drug substance collected in step (c) is reduced by at least 50% (w/w) as compared to the drug substance applied in step (a).