发明名称 ANTIBODY FORMULATION
摘要 The present invention relates to pharmaceutical formulations of a pharmaceutically active antigen binding protein, for example a monoclonal antibody. Such formulations comprise, in addition to the antigen binding protein, a buffering agent and a tonicity agent.
申请公布号 US2017095555(A1) 申请公布日期 2017.04.06
申请号 US201515311223 申请日期 2015.05.15
申请人 GlaxoSmithKline Intellectual Property Management Limited 发明人 BLAKE-HASKINS Angela;MARSHALL Tristan;PERKINS Melissa D.;O'BERRY Kristen
分类号 A61K39/395;C07K16/24;C07K16/28 主分类号 A61K39/395
代理机构 代理人
主权项 1. A pharmaceutical formulation for an antigen binding protein comprising: a. about 150 to 250 mg/mL antigen binding protein; b. about 1 to 100 mM of a buffering agent providing a pH of 6.0±0.5; c. about 90 to 150 mM of a tonicity agent; d. about 1 to 100 mM of a stabilizer; and e. about 0.005 to 0.015% (w/v) of a nonionic surfactant:wherein the antigen binding protein comprises amino acid sequences CDRH1 of SEQ ID NO: 11, CDRH2 of SEQ ID NO: 12, CDRH3 of SEQ ID NO: 13, CDRL1 of SEQ ID NO: 14, CDRL2 of SEQ ID NO:15, and CDRL3 of SEQ ID NO:16.
地址 Brentford, Middlesex GB