THOME, BRIAN M.,PARKHURST-LANG, CHERIE,LEVEILLE, BRANDON W.
申请号：
CA2943034
公开号：
CA2943034A1
申请日:
2015.03.24
申请国别(地区):
CA
年份:
2015
代理人:
摘要：
The present invention provides, among other things, pre-tyophilization 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-tyophilization 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) sufficient to allow (1) improved stability of the FIX polypeptide when lyophilized.
