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POWDER FORMULATION COMPRISING THROMBIN AND FIBRINOGEN
专利权人:
PROFIBRIX BV
发明人:
Laurens Adrianus Hendricus van Pinxteren,Glen Martyn,Nicola Kim Whitfield
申请号:
US14773212
公开号:
US20160015792A1
申请日:
2014.03.07
申请国别(地区):
US
年份:
2016
代理人:
摘要:
The invention relates to sterile powder compositions suitable for medical use comprising thrombin and fibrinogen, and to methods for producing the same, wherein the thrombin powder is produced from a liquid feedstock, wherein the feedstock comprises a solution or a suspension of thrombin, preferably a solution, wherein the powder is produced by removal of liquid by a process selected from aseptic spray drying or aseptic fluid bed drying, and wherein the powder resulting from removal of liquid from the feedstock exhibits at least 80% of the thrombin potency or activity of the liquid feedstock, and wherein the fibrinogen powder is produced by removal of liquid from a feedstock, wherein the feedstock comprises a solution or a suspension of fibrinogen, preferably a solution, by aseptic spray drying or aseptic fluid bed drying, and wherein said composition is packaged as a sterile final pharmaceutical product for medical use.
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