发明名称 Formulation of human antibodies for treating TNF-alpha 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 US9327032(B2) 申请公布日期 2016.05.03
申请号 US201514826357 申请日期 2015.08.14
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) a human IgG1 anti-human Tumor Necrosis Factor alpha (TNFα) antibody at a concentration of 50 mg/ml, (b) a polyol, (c) a polysorbate, and (d) a buffer system comprising histidine and having a pH of 4 to 8, wherein the antibody is D2E7, and wherein the formulation is suitable for subcutaneous injection.
地址 Hamilton BM
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