THOME, Brian M.,PARKHURST-LANG, Cherie,LEVEILLE, Brandon W.
申请号：
EP15769411
公开号：
EP3123090A4
申请日:
2015.03.24
申请国别(地区):
EP
年份:
2017
代理人:
摘要：
The present invention provides, among other things, pre-lyophilization formulations, reconstituted formulations, and lyophilate powder compositions comprising a Factor IX (FIX) polypeptide. The present invention also provides lyophilization methods for producing lyophilate powder comprising a FIX polypeptide. The present invention is directed to a pre-lyophilization formulation comprising: (a) a Factor IX (FIX) polypeptide having FIX coagulation activity (b) a buffering agent (c) a stabilizing agent (d) a bulking agent and (e) a surfactant, wherein the formulation has a fill volume of less than about 5 mL,and wherein each of (a)-(e) are at an amount per vial (mg/vial) Empty Vials sufficient to allow (1) improved stability of the FIX polypeptide when lyophilized.
