发明名称 |
High concentration formulations of anti-C5 antibodies |
摘要 |
The present disclosure relates to, inter alia, stable aqueous solutions comprising a high concentration of an antibody that binds to human complement component C5 and methods for preparing the solutions. The disclosure also provides methods for treating or preventing complement-associated disorders (for example, age-related macular degeneration or rheumatoid arthritis) using the solutions. Also featured are therapeutic kits containing one or more of the solutions and a means for administering the solutions to a patient in need such a treatment. |
申请公布号 |
US9415102(B2) |
申请公布日期 |
2016.08.16 |
申请号 |
US201213413268 |
申请日期 |
2012.03.06 |
申请人 |
Alexion Pharmaceuticals, Inc. |
发明人 |
Zhou Xiao-Hong;Wang Yi |
分类号 |
A61K39/395;C07K16/36;C07K16/18;A61K45/06;A61K39/00 |
主分类号 |
A61K39/395 |
代理机构 |
|
代理人 |
Fontenot J. Darrell;Remillard, Esq. Jane E.;Sloper, Esq. Jill Gorny |
主权项 |
1. A stable aqueous solution comprising:
(a) an anti-C5 antibody at a concentration of about 100 mg/mL to about 200 mg/mL, wherein the anti-C5 antibody comprises CDR1, CDR2, and CDR3 domains of a heavy chain comprising the amino acid sequence set forth in SEQ ID NO:13 and CDR1, CDR2, and CDR3 domains of a light chain comprising the amino acid sequence set forth in SEQ ID NO:12, (b) about 20 mM histidine, (c) about 50 mM serine, (d) about 3% (w/v) sorbitol, and (e) about 1.5% (w/v) mannitol. |
地址 |
New Haven CT US |