发明名称 |
Antibody formulations |
摘要 |
The present invention relates to formulations comprising sucrose, and methods of making such formulations, wherein the sucrose content promotes the reduction or elimination of the reversible self-association (RSA) tendency of the antibody in the formulation. The present invention also relates to formulations comprising an anti-PDGFR-alpha antibody or antibody fragment. Such antibodies can be used in various methods of treatment. The application further relates to a method of eliminating or reducing the RSA tendency of antibodies in a formulation. |
申请公布号 |
US8754195(B2) |
申请公布日期 |
2014.06.17 |
申请号 |
US201113175522 |
申请日期 |
2011.07.01 |
申请人 |
MedImmune, LLC |
发明人 |
Dimitrova Mariana N.;Mody Neil |
分类号 |
C07K16/28;C07K16/00 |
主分类号 |
C07K16/28 |
代理机构 |
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代理人 |
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主权项 |
1. A formulation, comprising:
a) an aqueous carrier; b) 1 mg/ml to 100 mg/ml of an antibody or antibody fragment that specifically binds to PDGFR-alpha and inhibits growth of cells that express PDGFR-alpha, wherein said antibody or antibody fragment in said formulation has substantially similar reversible self-association (RSA) characteristics at 2-8° C. and 23-27° C., as determined by analytical ultracentrifugation (AUC); c) 4% to 20% (weight/volume) sucrose; d) 0.01% to 0.1% (weight/volume) polysorbate 80 (PS80); and e) sodium-acetate buffer,wherein said formulation has a pH of pH 4.0 to pH 6.0.
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地址 |
Gaithersburg MD US |