发明名称 Formulation of human antibodies for treating TNF-α associated disorders
摘要 A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.
申请公布号 US8802102(B2) 申请公布日期 2014.08.12
申请号 US201414147287 申请日期 2014.01.03
申请人 AbbVie Biotechnology Ltd. 发明人 Krause Hans-Juergen;Baust Lisa;Dickes Michael
分类号 A61K39/395;C07K16/24;C07K14/525;A61K9/19;A61K47/10;A61K9/00;A61K47/26;A61K47/22;A61K47/18;A61K47/12 主分类号 A61K39/395
代理机构 Ropes & Gray LLP 代理人 Ropes & Gray LLP ;Haley, Jr. James F.;Li Z. Ying
主权项 1. A stable liquid aqueous pharmaceutical formulation comprising (a) a human IgG1 anti-human Tumor Necrosis Factor alpha (TNFα) antibody, or an antigen-binding portion thereof, at a concentration of 45 to 105 mg/ml, (b) a polyol, (c) a polysorbate at a concentration of 0.1 to 10 mg/ml, and (d) a buffer system comprising succinate and having a pH of 4.5 to 7.0, wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E7.
地址 Hamilton BM
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