发明名称 A LIQUID FORMULATION OF A FUSION PROTEIN COMPRISING TNFR AND FC REGION
摘要 The present invention relates to a liquid formulation comprising a TNFR-Fc fusion protein and a stabilizer, in which the fusion protein comprises TNFR (tumor necrosis factor receptor) or a fragment thereof and an immunoglobulin Fc region, and the stabilizer comprises one or more amino acids selected from the group consisting of proline and histidine, a buffer solution, and an isotonic agent containing sodium chloride (NaCl) and sucrose, and a preparation method of the liquid formulation. The liquid formulation according to the present invention provides excellent storage stability because long-term storage of TNFR-Fc fusion protein (etanercept) is possible and particular storage conditions are not needed. Since the liquid formulation of the present invention shows excellent storage stability even though the formulation is simple, it is more economical than other stabilizers or lyophilized formulations, and thus the formulation can be effectively applied for uses wherein treatment of TNFR-Fc fusion protein (etanercept) is beneficial.
申请公布号 CA2930227(A1) 申请公布日期 2015.06.04
申请号 CA20142930227 申请日期 2014.11.28
申请人 ARES TRADING S.A. 发明人 LEE, JUNG TAE;KIM, IN HYUK;YU, JAE KEUN;YIM, JUNG YIM;JEONG, MYEONG HYEON;AHN, YONG HO
分类号 A61K9/08;A61K39/395;A61K47/30 主分类号 A61K9/08
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