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1. 发明申请

WO2008079290A3 STABLE BUFFERED FORMULATIONS CONTAINING POLYPEPTIDES 审中-公开
标题翻译：含有多糖的稳定缓冲配方
公开(公告)号：WO2008079290A3
公开(公告)日：2008-12-04
申请号：PCT/US2007026060
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
IPC分类号： A61K47/22 , A61K9/08 , A61K39/395 , A61K47/18
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该制剂的方法。

2. 发明申请

WO2008045373A3 STABLE ANTIBODY FORMULATIONS 审中-公开
标题翻译：稳定的抗体制剂
公开(公告)号：WO2008045373A3
公开(公告)日：2008-10-16
申请号：PCT/US2007021477
申请日：2007-10-05
申请人： AMGEN INC , MCAULEY ARNOLD , REHDER DOUGLAS , MATSUMURA MASAZUMI
发明人： MCAULEY ARNOLD , REHDER DOUGLAS , MATSUMURA MASAZUMI
IPC分类号： A61K9/19 , A61K9/00 , A61K39/395 , A61K47/02 , A61K47/26
CPC分类号： A61K31/44 , A61K9/0019 , A61K9/19 , A61K31/5377 , A61K39/39591 , A61K47/12 , A61K47/26 , C07K16/2863 , C07K2317/21
摘要： The invention provides a formulation including an acetic acid buffer, a glutamic acid buffer or a succinic acid buffer with a pH from about 4.5-7.0, at least one excipient comprising a sugar or a polyol and an effective amount of a therapeutic antibody. The buffer can include a salt of acetate, glutamate or succinate and the sugar or polyol can include glycerol, sucrose, trehalose or sorbitol. The therapeutic antibody can include a human antibody, a humanized antibody, a chimeric antibody, or a functional fragment thereof.
摘要翻译：本发明提供了包含乙酸缓冲液，谷氨酸缓冲液或pH为约4.5-7.0的琥珀酸缓冲液，至少一种包含糖或多元醇的赋形剂和有效量的治疗性抗体的制剂。缓冲液可以包括乙酸盐，谷氨酸盐或琥珀酸盐，糖或多元醇可以包括甘油，蔗糖，海藻糖或山梨糖醇。治疗性抗体可以包括人抗体，人源化抗体，嵌合抗体或其功能片段。

3. 发明申请

WO2007016562A3 FORMULATIONS THAT INHIBIT PROTEIN AGGREGATION 审中-公开
公开(公告)号：WO2007016562A3
公开(公告)日：2007-02-08
申请号：PCT/US2006/029931
申请日：2006-07-31
申请人： AMGEN INC. , BRYCH, Stephen, R. , MATSUMURA, Masazumi
发明人： BRYCH, Stephen, R. , MATSUMURA, Masazumi
IPC分类号： A61K47/02
摘要： Disclosed is a stable pharmaceutically acceptable formulation containing a pharmaceutically acceptable amount of a protein. Also disclosed are methods for preparing such formulations and methods for inhibiting protein aggregate formation induced by physical stresses associated with processing, manufacture, shipping, and storing protein formulations, particularly freeze/thaw stress.

4. 发明申请

WO2007016562A2 FORMULATIONS THAT INHIBIT PROTEIN AGGREGATION 审中-公开
公开(公告)号：WO2007016562A2
公开(公告)日：2007-02-08
申请号：PCT/US2006029931
申请日：2006-07-31
申请人： AMGEN INC , BRYCH STEPHEN R , MATSUMURA MASAZUMI
发明人： BRYCH STEPHEN R , MATSUMURA MASAZUMI
IPC分类号： A61K47/02
CPC分类号： A61K47/10 , A61K47/02
摘要： Disclosed is a stable pharmaceutically acceptable formulation containing a pharmaceutically acceptable amount of a protein. Also disclosed are methods for preparing such formulations and methods for inhibiting protein aggregate formation induced by physical stresses associated with processing, manufacture, shipping, and storing protein formulations, particularly freeze/thaw stress.

5. 发明申请

WO2008051363A2 STABLE POLYPEPTIDE FORMULATIONS 审中-公开
标题翻译：稳定的多肽制剂
公开(公告)号：WO2008051363A2
公开(公告)日：2008-05-02
申请号：PCT/US2007/021475
申请日：2007-10-05
申请人： AMGEN INC. , REHDER, Douglas , BONDARENKO, Pavel , CHELIUS, Dirk , MCAULEY, Arnold , MATSUMURA, Masazumi
发明人： REHDER, Douglas , BONDARENKO, Pavel , CHELIUS, Dirk , MCAULEY, Arnold , MATSUMURA, Masazumi
IPC分类号： A61K9/00 , A61K47/02 , A61K47/26 , A61K39/395
CPC分类号： A61K47/26 , A61K9/0019 , A61K9/19 , A61K39/39591 , A61K47/02 , C07K16/2863 , C07K2317/21 , C07K2317/565
摘要： The invention provides a formulation including a buffer having a pH less than 6.0, a divalent cation between about 5-200 mM, an excipient comprising a sugar or polyol and an effective amount of a therapeutic polypeptide. Also provided is a method of stabilizing a polypeptide. The method includes contacting a therapeutic polypeptide with a concentration of divalent cation between about 5-150 150 mM in a buffer having a pH less than 6.0 and an excipient comprising a sugar or polyol.
摘要翻译：本发明提供了包含pH小于6.0，二价阳离子在约5-200mM之间的缓冲液，包含糖或多元醇的赋形剂和有效量的治疗性多肽的制剂。还提供了稳定多肽的方法。该方法包括使具有pH值小于6.0的缓冲液和包含糖或多元醇的赋形剂的二价阳离子浓度在约5-150±150mM之间的治疗性多肽接触。

6. 发明申请

WO2008045373A2 STABLE FORMULATIONS 审中-公开
标题翻译：稳定的公式
公开(公告)号：WO2008045373A2
公开(公告)日：2008-04-17
申请号：PCT/US2007/021477
申请日：2007-10-05
申请人： AMGEN INC. , MCAULEY, Arnold , REHDER, Douglas , MATSUMURA, Masazumi
发明人： MCAULEY, Arnold , REHDER, Douglas , MATSUMURA, Masazumi
IPC分类号： A61K9/20 , A61K31/44 , A61K31/5377
CPC分类号： A61K31/44 , A61K9/0019 , A61K9/19 , A61K31/5377 , A61K39/39591 , A61K47/12 , A61K47/26 , C07K16/2863 , C07K2317/21
摘要： The invention provides a formulation including an acetic acid buffer, a glutamic acid buffer or a succinic acid buffer with a pH from about 4.5-7.0, at least one excipient comprising a sugar or a polyol and an effective amount of a therapeutic antibody. The buffer can include a salt of acetate, glutamate or succinate and the sugar or polyol can include glycerol, sucrose, trehalose or sorbitol. The therapeutic antibody can include a human antibody, a humanized antibody, a chimeric antibody, or a functional fragment thereof.
摘要翻译：本发明提供了包含乙酸缓冲液，谷氨酸缓冲液或pH为约4.5-7.0的琥珀酸缓冲液，至少一种包含糖或多元醇的赋形剂和有效量的治疗性抗体的制剂。缓冲液可以包括乙酸盐，谷氨酸盐或琥珀酸盐，糖或多元醇可以包括甘油，蔗糖，海藻糖或山梨糖醇。治疗性抗体可以包括人抗体，人源化抗体，嵌合抗体或其功能片段。

7. 发明申请

WO2007124077A3 IMMUNOGLOBULIN CONSTANT REGION DOMAINS WITH ENHANCED STABILITY 审中-公开
公开(公告)号：WO2007124077A3
公开(公告)日：2007-11-01
申请号：PCT/US2007/009693
申请日：2007-04-20
申请人： AMGEN, INC. , MATSUMURA, Masazumi , JACOB, Jaby
发明人： MATSUMURA, Masazumi , JACOB, Jaby
IPC分类号： C07K16/00 , A61P35/00 , A61P37/00
摘要： The invention provides an isolated polypeptide including an immunoglobulin C H 3 region domain polypeptide, or functional fragment thereof, having at least one Pro to GIy substitution and exhibiting enhanced stability, including an enhanced folding rate, compared to an unsubstituted C H 3 domain, wherein the at least one Pro to GIy substitution comprises C H 3 residue Pro38 or a C H 3 domain equivalent thereof. Multimeric complexes of an immunoglobulin C H 3 region domain polypeptide, or functional fragment thereof, having at least one Pro to GIy substitution with a second immunoglobulin C H 3 region domain polypeptide also are provided by the invention. The multimeric complexes can include antibodies, antibody functional fragments such as Fd, Fv, Fab, F(ab'), F(ab) 2 , F(ab') 2 , single chain Fv (scFv), chimeric antibodies, diabodies, triabodies, tetrabodies or minibody and other binding polypeptides having an immunoglobulin C H 3 region domain polypeptide such as a peptibody or an Fc fusion polypeptide. An isolated population of polypeptides including a plurality of immunoglobulin C H 3 region domain polypeptides, or functional fragments thereof, is further provided. Each C H 3 region domain polypeptide within the populations includes at least one Pro to GIy substitution and exhibits enhanced stability, including an enhanced folding rate, compared to an unsubstituted C H 3 domain, wherein the at least one Pro to GIy substitution comprises C H 3 residue Pro38 or a C H 3 domain equivalent thereof. The invention further provides a method of producing a multimeric binding polypeptide and a method of treating a pathological condition characterized by aberrant cell growth.

8. 发明申请

WO2008051363A3 STABLE POLYPEPTIDE FORMULATIONS 审中-公开
标题翻译：稳定的多肽配方
公开(公告)号：WO2008051363A3
公开(公告)日：2008-09-12
申请号：PCT/US2007021475
申请日：2007-10-05
申请人： AMGEN INC , REHDER DOUGLAS , BONDARENKO PAVEL , CHELIUS DIRK , MCAULEY ARNOLD , MATSUMURA MASAZUMI
发明人： REHDER DOUGLAS , BONDARENKO PAVEL , CHELIUS DIRK , MCAULEY ARNOLD , MATSUMURA MASAZUMI
IPC分类号： A61K9/19 , A61K9/00 , A61K39/395 , A61K47/02 , A61K47/26
CPC分类号： A61K47/26 , A61K9/0019 , A61K9/19 , A61K39/39591 , A61K47/02 , C07K16/2863 , C07K2317/21 , C07K2317/565
摘要： The invention provides a formulation including a buffer having a pH less than 6.0, a divalent cation between about 5-200 mM, an excipient comprising a sugar or polyol and an effective amount of a therapeutic polypeptide. Also provided is a method of stabilizing a polypeptide. The method includes contacting a therapeutic polypeptide with a concentration of divalent cation between about 5-150 150 mM in a buffer having a pH less than 6.0 and an excipient comprising a sugar or polyol.
摘要翻译：本发明提供了包含pH小于6.0的缓冲液，约5-200mM的二价阳离子，包含糖或多元醇的赋形剂和有效量的治疗性多肽的制剂。还提供了稳定多肽的方法。该方法包括在pH小于6.0的缓冲液和包含糖或多元醇的赋形剂之间使治疗性多肽与浓度为约5-150 150mM的二价阳离子接触。

9. 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。

10. 发明申请

WO2007124077A2 IMMUNOGLOBULIN CONSTANT REGION DOMAINS WITH ENHANCED STABILITY 审中-公开
标题翻译：具有增强稳定性的免疫球蛋白恒定区域
公开(公告)号：WO2007124077A2
公开(公告)日：2007-11-01
申请号：PCT/US2007009693
申请日：2007-04-20
申请人： AMGEN INC , MATSUMURA MASAZUMI , JACOB JABY
发明人： MATSUMURA MASAZUMI , JACOB JABY
IPC分类号： C07K19/00 , A61P35/00 , A61P37/00 , C07K16/00
CPC分类号： C07K16/00 , C07K2317/52
摘要： The invention provides an isolated polypeptide including an immunoglobulin C H 3 region domain polypeptide, or functional fragment thereof, having at least one Pro to GIy substitution and exhibiting enhanced stability, including an enhanced folding rate, compared to an unsubstituted C H 3 domain, wherein the at least one Pro to GIy substitution comprises C H 3 residue Pro38 or a C H 3 domain equivalent thereof. Multimeric complexes of an immunoglobulin C H 3 region domain polypeptide, or functional fragment thereof, having at least one Pro to GIy substitution with a second immunoglobulin C H 3 region domain polypeptide also are provided by the invention. The multimeric complexes can include antibodies, antibody functional fragments such as Fd, Fv, Fab, F(ab'), F(ab) 2 , F(ab') 2 , single chain Fv (scFv), chimeric antibodies, diabodies, triabodies, tetrabodies or minibody and other binding polypeptides having an immunoglobulin C H 3 region domain polypeptide such as a peptibody or an Fc fusion polypeptide. An isolated population of polypeptides including a plurality of immunoglobulin C H 3 region domain polypeptides, or functional fragments thereof, is further provided. Each C H 3 region domain polypeptide within the populations includes at least one Pro to GIy substitution and exhibits enhanced stability, including an enhanced folding rate, compared to an unsubstituted C H 3 domain, wherein the at least one Pro to GIy substitution comprises C H 3 residue Pro38 or a C H 3 domain equivalent thereof. The invention further provides a method of producing a multimeric binding polypeptide and a method of treating a pathological condition characterized by aberrant cell growth.
摘要翻译：本发明提供了一种分离的多肽，其包含免疫球蛋白C 3区域结构域多肽或其功能片段，其具有至少一个Pro至Gly取代并表现出增强的稳定性，包括增强的折叠率，与未取代的C 3 H 3结构域，其中至少一个Pro至Gly取代包括C 3 H 3残基Pro38或其C 3 H 3结构域等同物。具有与第二免疫球蛋白C区域结构域多肽进行至少一个Pro至Gly取代的免疫球蛋白C H 3区域多肽或其功能片段的多聚体复合物也由本发明提供。多聚体复合物可以包括抗体，抗体功能片段，例如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，四体抗体或微型抗体以及其它具有免疫球蛋白C H 3区域结构域多肽的结合多肽，例如肽型或Fc融合多肽。还提供了分离的多肽包括多个免疫球蛋白C 3区域结构域多肽或其功能片段。与未取代的C 3 H 3相比，群体内的每个C 3 H 3域结构域多肽包含至少一个Pro至Gly取代并表现出增强的稳定性，包括增强的折叠率其中所述至少一个Pro至Gly取代包括C 3 H 3残基Pro38或其C 3 H 3结构域等同物。本发明进一步提供了一种制备多聚结合多肽的方法和一种治疗以异常细胞生长为特征的病理状态的方法。

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