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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

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.

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

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。

5. 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。

6. 发明授权

EP2129401B1 STABLE BUFFERED FORMULATIONS CONTAINING POLYPEPTIDES 有权转让
公开(公告)号：EP2129401B1
公开(公告)日：2019-07-17
申请号：EP07863175.1
申请日：2007-12-19
申请人： Amgen, Inc
发明人： JACOB, Jaby , MATSUMURA, Masazumi , GOKARN, Yatin , BREMS, David
IPC分类号： A61K47/22 , A61K39/395 , A61K47/18 , A61K9/08
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.

7. 发明授权

EP2129401B8 STABLE BUFFERED FORMULATIONS CONTAINING POLYPEPTIDES 有权转让
公开(公告)号：EP2129401B8
公开(公告)日：2019-10-30
申请号：EP07863175.1
申请日：2007-12-19
申请人： Amgen Inc
发明人： JACOB, Jaby , MATSUMURA, Masazumi , GOKARN, Yatin , BREMS, David
IPC分类号： A61K47/22 , A61K39/395 , A61K47/18 , A61K9/08

8. 发明公开

EP2129401A2 STABLE BUFFERED FORMULATIONS CONTAINING POLYPEPTIDES 有权转让
标题翻译：稳定的缓冲剂制剂含有多肽
公开(公告)号：EP2129401A2
公开(公告)日：2009-12-09
申请号：EP07863175.1
申请日：2007-12-19
申请人： Amgen, Inc
发明人： JACOB, Jaby , MATSUMURA, Masazumi , GOKARN, Yatin , BREMS, David
IPC分类号： A61K47/22 , A61K39/395 , A61K47/18 , A61K9/08
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.

9. 发明授权

EP2081553B1 STABLE ANTIBODY FORMULATIONS 有权转让
公开(公告)号：EP2081553B1
公开(公告)日：2020-08-12
申请号：EP07839335.2
申请日：2007-10-05
申请人： Amgen Inc.
发明人： MCAULEY, Arnold , REHDER, Douglas , MATSUMURA, Masazumi
IPC分类号： A61K9/19 , A61K47/02 , A61K47/26 , A61K9/00 , A61K39/395

10. 发明授权

EP2027154B1 IMMUNOGLOBULIN CONSTANT REGION DOMAINS WITH ENHANCED STABILITY 有权
标题翻译：免疫球蛋白的恒定区的稳定性改进DOMAINS
公开(公告)号：EP2027154B1
公开(公告)日：2012-04-18
申请号：EP07755812.0
申请日：2007-04-20
申请人： AMGEN INC.
发明人： MATSUMURA, Masazumi , JACOB, Jaby
IPC分类号： C07K16/00 , A61P35/00 , A61P37/00
CPC分类号： C07K16/00 , C07K2317/52
摘要： The invention provides an isolated polypeptide including an immunoglobulin CH3 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 CH3 domain, wherein the at least one Pro to GIy substitution comprises CH3 residue Pro38 or a CH3 domain equivalent thereof. Multimeric complexes of an immunoglobulin CH3 region domain polypeptide, or functional fragment thereof, having at least one Pro to GIy substitution with a second immunoglobulin CH3 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 CH3 region domain polypeptide such as a peptibody or an Fc fusion polypeptide. An isolated population of polypeptides including a plurality of immunoglobulin CH3 region domain polypeptides, or functional fragments thereof, is further provided. Each CH3 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 CH3 domain, wherein the at least one Pro to GIy substitution comprises CH3 residue Pro38 or a CH3 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.

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