发明名称 Antibody-containing solution formulations
摘要 Antibody-containing solution formulations including a sugar as a stabilizer. Said solution formulations can further include a surfactant as a stabilizer.
申请公布号 US9051384(B2) 申请公布日期 2015.06.09
申请号 US200912349986 申请日期 2009.01.07
申请人 CHUGAI SEIYAKU KABUSHIKI KAISHA 发明人 Kakuta Masaya;Kikuchi Jun;Mizushima Hidefumi;Imaeda Yoshimi
分类号 A61K39/395;C07K16/44;A61K9/00;A61K47/10;A61K47/12;A61K47/26;C07K16/30;C07K16/40;A61K39/00 主分类号 A61K39/395
代理机构 Browdy and Neimark, PLLC 代理人 Browdy and Neimark, PLLC
主权项 1. A method for stabilizing a humanized anti-interleukin-6 receptor IgG1 antibody during freeze/thaw of a solution formulation comprising the antibody, wherein the method comprises combining 17.5 to 22.5 mg/ml of the antibody with a phosphate buffer, and with surfactant and sugar as stabilizers, wherein the pH of the formulation is 6.5 to 7.0, and the sugar is sucrose or trehalose, wherein the sugar is in an amount from 25 to 100 mg/ml.
地址 Tokyo JP