| 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 |
US2016030578(A1) |
申请公布日期 |
2016.02.04 |
| 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 |
A61K47/26;A61K47/12;A61K47/22;C07K16/24;A61K47/10 |
主分类号 |
A61K47/26 |
| 代理机构 |
|
代理人 |
|
| 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 |
