Lee, Jung Tae,Kim, In Hyuk,Yu, Jae Keun,Yim, Jung Yim,Jeong, Myeong Hyeon,Ahn, Yong Ho
申请号：
AU2014354384
公开号：
AU2014354384B2
申请日:
2014.11.28
申请国别(地区):
AU
年份:
2018
代理人:
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.
