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STABILIZED FORMULATIONS CONTAINING ANTI-NGF ANTIBODIES
专利权人:
Inc.;Regeneron Pharmaceuticals
发明人:
Walsh, Scott,Potocky, Terra,Dix, Daniel,Sivendran, Renuka
申请号:
AU2015202886
公开号:
AU2015202886B2
申请日:
2015.05.27
申请国别(地区):
AU
年份:
2016
代理人:
摘要:
#$%^&*AU2015202886B220160421.pdf#####ABSTRACT The present invention provides a method for maintaining the stability of an antibody in a formulation, comprising: storing an antibody formulation for six months or more at 51C or more; wherein the antibody formulation comprises: (i) about 0.1 to 100 mg/ml of a human antibody that specifically binds to human nerve growth factor (hNGF), wherein the antibody comprises a heavy chain and light chain variable region (HCVR / LCVR) amino acid sequence pairs selected from the group consisting of: (i) SEQ ID NOs: 20/22; and (ii) SEQ ID NOs: 4/12; (ii) about 0.01 to 1.0% of a polysorbate 20; (iii) about 1 to 20% of sucrose; and (iv) about 1 mM to about 50 mM acetate; whereby the stored formulation maintains stability such that 90% or more of the antibody is detected by size-exclusion high-performance liquid chromatography (SE-HPLC).
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中国工程科技知识中心
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