发明名称 BUFFERING AGENTS FOR BIOPHARMACEUTICAL FORMULATIONS.
摘要 <p>The invention provides a biopharmaceutical formulation including an aqueous solution having a propionate buffer with a pH from about 4.0 to about 6.0, at least one excipient and an effective amount of a therapeutic polypeptide. The propionate buffer can include a concentration selected from between about 1-50 mM, 2-30 mM, 3-20 mM, 4-10 mM and 5-8 mM. The therapeutic polypeptide included in a biopharmaceutical formulation of the invention can include an antibody, Fd, Fv, Fab, F(ab'), F(ab)2, F(ab')2, single chain Fv (scFv), chimeric antibodies, diabodies, triabodies, tetrabodies, minibody, peptibody, hormone, growth factor or cell signaling molecule. The invention also provides a method of preparing a biopharmaceutical formulation. The method includes combining an aqueous solution having a propionate buffer with a pH from about 4.0 to about 6.0 and at least one excipient with an effective amount of a therapeutic polypeptide.</p>
申请公布号 MX2008013535(A) 申请公布日期 2008.10.29
申请号 MX20080013535 申请日期 2007.04.19
申请人 AMGEN INC. 发明人 GOKARN, YATIN
分类号 A61K47/12;A61K9/08;A61K39/395;A61K47/26;A61K47/34 主分类号 A61K47/12
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