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 |
US2014314781(A1) |
申请公布日期 |
2014.10.23 |
申请号 |
US201414322565 |
申请日期 |
2014.07.02 |
申请人 |
AbbVie Biotechnology Ltd |
发明人 |
Krause Hans-Juergen;Baust Lisa;Dickes Michael |
分类号 |
A61K47/26;A61K39/395;A61K47/12;C07K16/24 |
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) a human IgG1 anti-human Tumor Necrosis Factor alpha (TNFα) antibody, or an antigen-binding portion thereof, at a concentration of 20 to 150 mg/ml, (b) a polyol, (c) a surfactant, and (d) a buffer system comprising gluconate and having a pH of 4.0 to 8.0, wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E7. |
地址 |
Hamilton BM |