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1. 发明申请

WO2008079290A2 FORMULATIONS 审中-公开
标题翻译：配方
公开(公告)号：WO2008079290A2
公开(公告)日：2008-07-03
申请号：PCT/US2007/026060
申请日：2007-12-19
申请人： AMGEN INC , JACOB, Jaby , MATSUMURA, Masazumi , GOKARN, Yatin , BREMS, David
发明人： JACOB, Jaby , MATSUMURA, Masazumi , GOKARN, Yatin , BREMS, David
CPC分类号： C07K16/22 , A61K9/0019 , A61K9/08 , A61K47/12 , A61K47/183 , A61K47/22 , C07K2317/94
摘要： The invention provides a formulation comprising a buffer with a pH from about 4.0 to about 6.0, proline and an effective amount of a polypeptide. The polypeptide can be an antibody. The specification also provides methods of preparing the formulation, a kit containing the formulation and methods of using the formulation.
摘要翻译：本发明提供一种包含pH为约4.0至约6.0的缓冲液，脯氨酸和有效量的多肽的制剂。多肽可以是抗体。说明书还提供了制备制剂的方法，包含制剂的试剂盒和使用制剂的方法。

2. 发明申请

WO2007124082A2 BUFFERING AGENTS FOR BIOPHARMACEUTICAL FORMULATIONS 审中-公开
标题翻译：生物制剂制剂的缓冲剂
公开(公告)号：WO2007124082A2
公开(公告)日：2007-11-01
申请号：PCT/US2007/009700
申请日：2007-04-19
申请人： AMGEN, INC. , GOKARN, Yatin
发明人： GOKARN, Yatin
IPC分类号： A61K47/26 , A61K47/34 , A61K39/395
CPC分类号： C07K16/2803 , A61K9/0019 , A61K39/39591 , A61K47/12
摘要： 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.
摘要翻译：本发明提供了一种生物药物制剂，其包括具有约4.0至约6.0的pH的丙酸缓冲液的水溶液，至少一种赋形剂和有效量的治疗性多肽。丙酸盐缓冲液可以包括选自约1-50mM，2-30mM，3-20mM，4-10mM和5-8mM之间的浓度。包含在本发明的生物药物制剂中的治疗性多肽可以包括抗体Fd，Fv，Fab，F（ab'），F（ab）2，F（ab'）2 单链Fv（scFv），嵌合抗体，双抗体，三抗体，四体抗体，微型抗体，肽性抗体，激素，生长因子或细胞信号传导分子。本发明还提供了制备生物药物制剂的方法。该方法包括将具有丙酸盐缓冲液的水溶液与约4.0至约6.0的pH和至少一种赋形剂与有效量的治疗性多肽组合。

3. 发明申请

WO2015095568A1 REDUCTION OF LIPASE ACTIVITY IN PRODUCT FORMULATIONS 审中-公开
标题翻译：减少产品配方中的脂肪酶活性
公开(公告)号：WO2015095568A1
公开(公告)日：2015-06-25
申请号：PCT/US2014/071234
申请日：2014-12-18
申请人： LEE, Kelvin , LENHOFF, Abraham , VALENTE, Kristen , LEVY, Nick , GOKARN, Yatin
发明人： LEE, Kelvin , LENHOFF, Abraham , VALENTE, Kristen , LEVY, Nick , GOKARN, Yatin
IPC分类号： C12N1/08
CPC分类号： C12N15/1137 , A61K38/1709 , A61K38/1741 , A61K38/1761 , A61K38/1774 , A61K38/39 , A61K38/42 , A61K38/44 , A61K38/443 , A61K38/45 , A61K38/4813 , A61K38/482 , A61K38/488 , A61K38/52 , A61K47/26 , C07K16/00 , C12N9/20 , C12N2310/10 , C12N2310/14 , C12N2310/20 , C12P21/005 , C12P21/02 , C12Y104/03013 , C12Y111/01015 , C12Y205/01018 , C12Y207/04006 , C12Y207/11001 , C12Y301/01034 , C12Y304/16005 , C12Y304/21 , C12Y304/23005 , C12Y502/01008 , C12Y503/04001
摘要： The invention relates a method for producing a stable recombinant protein, comprising growing a non-naturally occurring host cell in a culture medium to produce a recombinant protein, and making a composition comprising the recombinant protein and a polysorbate. The production of endogenous lipoprotein lipase by the host cell is reduced. The endogenous lipoprotein lipase is present in the composition in a small amount, and is capable of degrading the polysorbate. The invention also relates to the relevant host cells and compositions, and preparation thereof.
摘要翻译：本发明涉及一种生产稳定重组蛋白的方法，包括在培养基中培养非天然存在的宿主细胞以产生重组蛋白，以及制备包含重组蛋白和聚山梨酯的组合物。由宿主细胞产生的内源性脂蛋白脂肪酶降低。内源性脂蛋白脂肪酶以少量存在于组合物中，并且能够降解聚山梨醇酯。本发明还涉及相关宿主细胞和组合物及其制备。

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