| abstract |
The present invention provides novel compositions and highly concentrated, liquid and lyophilized Factor IX formulations suitable for storage and administration. A composition comprising factor IX and arginine, more particularly from the group consisting of about 0.1 mg / ml to 160 mg / ml factor IX, glycine, a surfactant, and a buffering agent and a cryoprotectant. The composition comprising the selected member increases the stability of the Factor IX protein during the concentration and lyophilization processes, maintains the activity level, and is stable during long-term storage at 2-8 ° C for more than 1 year Prescription. [Selection figure] None |