Patent ID: 8703706

Claim:
A process for the preparation of a concentrated solution of activated recombinant Factor VII polypeptide, said solution comprising in the range of from about 16 to about 25 mg of the activated Factor VII polypeptide per mL volume of a closed container, wherein, said process comprises the steps of: (a) contacting a solution comprising a recombinant Factor VII polypeptide with an anion-exchange material under conditions which facilitate binding of a portion of said Factor VII polypeptide to said anion-exchange material said Factor VII solution having a pH in the range of 5.5-7.0, or a pH in the range of 8.5-9.5 with the presence of at least 15 mM Ca 2+ ; (b) washing said anion-exchange material with a washing buffer having a pH in the range of 5.5-7.0; and (c) eluting said anion-exchange material with an elution buffer having a pH in the range of 3.0-7.0, and comprising calcium ions (Ca +2 ) in a concentration of at least 15 mM; and collecting the eluate of the activated Factor VII polypeptide; (d) loading at least a portion of the eluate into a container so that the container comprises in the range of from about 16 to about 25 mg of the activated Factor VII polypeptide per mL volume of the container; (e) optionally lyophilizing the eluate; and (f) sealing the container so as to provide a closed container.