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 |