| abstract |
The invention provides, inter alia, pre-lyophilization formulations, reconstituted formulations, a lyophilized powder, and a vial containing Factor IX (FIX) polypeptide. The invention relates to a preliophilization composition containing (a) a factor IX (FIX) polypeptide; (b) L-histidine; (c) sucrose; (d) mannitol and (e) polysorbate 20, wherein components (a) to (e) are contained in the amounts indicated in the claims, and the filling volume of the composition is from 2 to 3 ml. |