Liquid formulation of a fusion protein comprising TNFR and Fc region

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...

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Bibliographische Detailangaben
Hauptverfasser: Lee Jung Tae, Kim In Hyuk, Yu Jae Keun, Yim Jung Yim, Jeong Myeong Hyeon, Ahn Yong Ho
Format: Patent
Sprache:eng
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Zusammenfassung: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.