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公开(公告)号：EP1827483A2
公开(公告)日：2007-09-05
申请号：EP05853972.7
申请日：2005-12-12
申请人： Amgen Inc.
CPC分类号： A61K9/19 , A61K38/1825 , A61K47/183 , A61K47/26 , C07K14/50
摘要： The present invention provides long-term stable formulations of lyophilized keratinocyte growth factor and methods for making a lyophilized composition comprising keratinocyte growth factor.
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公开(公告)号：EP1228086B1
公开(公告)日：2008-08-27
申请号：EP00978458.8
申请日：2000-11-10
申请人： AMGEN INC.
IPC分类号： C07K1/113
CPC分类号： C07K1/1133 , C07K14/70578 , C07K2319/00 , C07K2319/30 , Y10S530/825 , Y10S530/866 , Y10S530/867
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公开(公告)号：EP1228086A1
公开(公告)日：2002-08-07
申请号：EP00978458.8
申请日：2000-11-10
申请人： AMGEN INC.
IPC分类号： C07K1/113
CPC分类号： C07K1/1133 , C07K14/70578 , C07K2319/00 , C07K2319/30 , Y10S530/825 , Y10S530/866 , Y10S530/867
摘要： The present invention concerns a process by which a misfold in an Fc fusion molecule can be prevented or corrected. In one embodiment, the process comprises (a) preparing a pharmacologically active compound comprising an Fc domain; (b) treating the fusion molecule with a copper (II) halide; and (c) isolating the treated fusion molecule. The preferred copper (II) halide is CuCl2. The preferred concentration thereof is at least about 10 mM for fusion molecules prepared in E. coli; at least about 30 mM for fusion molecules prepared in CHO cells. Preferred pharmacologically active domains include OPG proteins, leptin proteins, soluble portions of TNF receptors (e.g., wherein the fusion molecule is etanercept), IL-1ra proteins, and TPO-mimetic peptides. The Fc domain preferably has a human sequence, with an Fc sequence derived from IgG1 most preferred.
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