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 US9302011(B2) 申请公布日期 2016.04.05
申请号 US201514884279 申请日期 2015.10.15
申请人 ABBVIE BIOTECHNOLOGY LTD 发明人 Krause Hans-Juergen;Baust Lisa;Dickes Michael
分类号 A61K39/395;C07K16/00;C07K16/22;A61K47/26;A61K9/19;C07K16/24;A61K9/00;A61K47/10;A61K47/12;A61K47/22;A61K47/18;A61K47/02;C07K14/525;A61K39/00 主分类号 A61K39/395
代理机构 Ropes & Gray LLP 代理人 Ropes & Gray LLP ;Haley, Jr. James F.;Gummow Brian M.
主权项 1. A stable liquid aqueous pharmaceutical formulation comprising (a) 50 mg/ml of a human IgG1 anti-human Tumor Necrosis Factor alpha (TNFα) antibody, wherein the antibody comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO:1 and a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 2; (b) a polyol; (c) a polysorbate; and (d) a buffer system comprising an organic acid; wherein the formulation has a pH of 4 to 8, and wherein the formulation is suitable for subcutaneous injection.
地址 Hamilton BM
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