摘要 |
<P>PROBLEM TO BE SOLVED: To provide a new composition and a highly concentrated, liquid and lyophilized factor IX formulation suitable for storage and administration. Ž<P>SOLUTION: The composition contains the factor IX and arginine. For further detail, the stability of the factor IX protein during a concentrating process and a lyophilizing process is improved, and the activity level can be maintained to provide the formulation stable during prolonged storage for one year or longer at 2-8°C by the composition containing about 0.1-160 mg/ml of the factor IX, glycine, a surfactant, and a member selected from the group consisting of a buffering agent and a cryoprotectant. Ž<P>COPYRIGHT: (C)2010,JPO&INPIT Ž
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