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פורמולציות של פקטור ix שעברו ליאופיליזציה
专利权人:
BIOGEN MA INC.;BIOVERATIV THERAPEUTICS INC.
发明人:
申请号:
IL24786916
公开号:
IL247869D0
申请日:
2016.09.18
申请国别(地区):
IL
年份:
2016
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.
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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