发明名称 |
PROTEIN FORMULATION COMPRISING COAGULATION FACTOR VIII OR FACTOR IX IN AN AQUEOUS SOLUTION |
摘要 |
The present invention relates to a final drug product of a plasma protein selected from the group consisting of coagulation factor VIII and factor IX, in a aqueous solution, wherein the concentration of oxygen in the solution is reduced and/or the solution contains an antioxidant, and wherein the solution further contains a carbohydrate in a concentration of at least 350 mg/ml. In this way, the protein activity can be essentially retained after storage for at least 6 months. The present invention also relates to a process for preparing the final drug product, and a method for improving the long-term stability of coagulation factor VIII and factor IX in an aqueous solution, wherein the solution contains a carbohydrate in a concentration of at least 350 mg/ml, and wherein the solution is stored in its final container under an oxygen-reduced atmosphere.
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申请公布号 |
WO9630041(A1) |
申请公布日期 |
1996.10.03 |
申请号 |
WO1996SE00419 |
申请日期 |
1996.03.29 |
申请人 |
PHARMACIA AB;OESTERBERG, THOMAS;FATOUROS, ANGELICA |
发明人 |
OESTERBERG, THOMAS;FATOUROS, ANGELICA |
分类号 |
A61K47/26;A61K35/16;A61K38/37;A61K38/43;A61K38/48;A61K38/57;C07K14/755;(IPC1-7):A61K38/37;A61K38/36 |
主分类号 |
A61K47/26 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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