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1. 发明申请

WO2018141910A1 LOW PH PHARMACEUTICAL COMPOSITION COMPRISING T CELL ENGAGING ANTIBODY CONSTRUCTS 审中-公开
公开(公告)号：WO2018141910A1
公开(公告)日：2018-08-09
申请号：PCT/EP2018/052665
申请日：2018-02-02
申请人： AMGEN RESEARCH (MUNICH) GMBH , AMGEN INC.
发明人： MCAULEY, Arnold , GHATTYVENKATAKRISHNA, Pavan , ABEL, Jeff , HUH, Joon , POMPE, Cornelius , KANAPURAM, Sekhar , TREUHEIT, Michael , JAGANNATHAN, Bharadwaj
IPC分类号： A61K39/395 , C07K16/28
摘要： The present disclosure provides a low pH pharmaceutical composition comprising (a) an antibody constructs comprising a first domain binding to a target cell surface antigen, a second domain binding to a second antigen and preferably a third domain, which is a specific Fc modality, (b) at least one buffer agent, (c) at least one saccharide, and (d) at least one surfactant; and wherein the pH of the pharmaceutical composition is in the range of 3.5 to 6.

2. 发明申请

WO2022096698A1 POLYPEPTIDE CONSTRUCTS BINDING TO CD3 审中-公开
公开(公告)号：WO2022096698A1
公开(公告)日：2022-05-12
申请号：PCT/EP2021/080859
申请日：2021-11-08
申请人： AMGEN INC. , AMGEN RESEARCH (MUNICH) GMBH
发明人： RAU, Doris , RAUM, Tobias , HOFFMANN, Patrick , MUENZ, Markus , KLINGER, Matthias , NAEGELE, Virgine , WINKEL, Lisa , GHATTYVENKATAKRISHNA, Pavan , HUH, Joon Hoi , MCAULEY, Arnold , KANAPURAM, Sekhar
IPC分类号： C07K16/28 , A61P35/00
摘要： The invention relates to a polypeptide or polypeptide construct comprising: a binding domain binding to an extracellular epitope of the human CD3s chain comprising or consisting of a VH region and a VL region, wherein i) the VH region comprises: a CDR- H1 sequence of X1YAX2N, where X1 is K, V, S, G, R, T, or I; and X2 is M or I; a CDR-H2 sequence of RIRSKYNNYATYYADX1VKX2, where Χ1 is S or Q; and X2 is D, G, K, S, or E; and a CDR-H3 sequence of HX1NFGNSYX2SX3X4AY, where ΧΊ is G, R, or A; X2 is I, L, V, or T; X3 is Y, W or F; and X4 is W, F or Y; and ii) wherein the VL region comprises: a CDR-L1 sequence of ΧΊ SSTGAVTX2X3X4YX5N, where ΧΊ is G, R, or A; X2 is S or T; X3 is G or S; X4 is N or Y; and X5 is P or A; a CDR-L2 sequence of X1TX2X3X4X5X6; where Χ1 is G or A; X2 is K, D, or N; X3 is F, M or K; X4 is L or R; X5 is A, P, or V; and X6 is P or S; and a CDR-L3 sequence of X1LWYSNX2VW, where X1 is V, A, or T; and X2 is R or L; and iii) wherein one or more of CDR sequences of the VH region of i) and/or of the VL region of ii) comprise one amino acid substitution or a combination thereof selected from X24V and X24F in CDR-H1; D15, and X116A in CDR-H2; H1, X12E, F4, and N6 in CDR-H3; and X11L and W3 in CDR-L3. The invention also relates to a polynucleotide encoding the polypeptide or polypeptide construct of the invention, a vector comprising said polynucleotide and a host cell transformed or transfected with said polynucleotide or with said vector. Moreover, the invention also provides for a process for the production of said polypeptide or polypeptide construct and a pharmaceutical composition comprising said polypeptide or polypeptide construct of the invention. Furthermore, the invention relates to medical uses of said polypeptide or polypeptide construct and kits comprising said polypeptide or polypeptide construct.

3. 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。

4. 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。

5. 发明公开

EP3576788A1 LOW PH PHARMACEUTICAL COMPOSITION COMPRISING T CELL ENGAGING ANTIBODY CONSTRUCTS 审中-公开
公开(公告)号：EP3576788A1
公开(公告)日：2019-12-11
申请号：EP18706965.3
申请日：2018-02-02
申请人： Amgen Research (Munich) GmbH , Amgen Inc.
发明人： MCAULEY, Arnold , GHATTYVENKATAKRISHNA, Pavan , ABEL, Jeff , HUH, Joon , POMPE, Cornelius , KANAPURAM, Sekhar , TREUHEIT, Michael , JAGANNATHAN, Bharadwaj
IPC分类号： A61K39/395 , C07K16/28

6. 发明申请

WO2022256359A1 ACCELERATED METHOD OF MAKING LYOPHILIZED PROTEIN FORMUALTIONS 审中-公开
公开(公告)号：WO2022256359A1
公开(公告)日：2022-12-08
申请号：PCT/US2022/031694
申请日：2022-06-01
申请人： AMGEN INC.
发明人： MCCORMICK, Jeff , MCAULEY, Arnold
IPC分类号： A61K9/19 , A61K38/00 , A61K47/12 , A61K47/26
摘要： Disclosed herein are accelerated methods of preparing lyophilized formulations comprising a protein, such as an antibody or a bispecific antigen-binding molecule that exhibit improved storage stability.

7. 发明申请

WO2022056455A1 METHOD OF MAKING LYOPHILIZED PROTEIN FORMULATIONS 审中-公开
公开(公告)号：WO2022056455A1
公开(公告)日：2022-03-17
申请号：PCT/US2021/050238
申请日：2021-09-14
申请人： AMGEN INC.
发明人： MCAULEY, Arnold , TREUHEIT, Michael, J. , CHRISTIAN, Twinkle, R. , JAGANNATHAN, Bharadwaj
IPC分类号： A61K9/19 , A61K38/16 , A61K38/17 , A61K38/20 , A61K39/395 , C07K14/00
摘要： Disclosed herein are methods of preparing lyophilized formulations comprising a protein, such as an antibody or a bispecific antibody construct, that exhibits improved storage stability.

8. 发明申请

WO2018204907A1 PHARMACEUTICAL COMPOSITION COMPRISING BISPECIFIC ANTIBODY CONSTRUCTS FOR IMPROVED STORAGE AND ADMINISTRATION 审中-公开
公开(公告)号：WO2018204907A1
公开(公告)日：2018-11-08
申请号：PCT/US2018/031347
申请日：2018-05-07
申请人： AMGEN INC.
发明人： ABEL, Jeff , CUI, Lingwen , GOSWAMI, Devrishi , HUH, Joon , JAGANNATHAN, Bharadwaj , KANAPURAM, Sekhar , MCAULEY, Arnold , SCHNEIDER, Michael , SETHURAMAN, Ananthakrishnan, G. , TREUHEIT, Michael , ZHANG, Jun
IPC分类号： A61K39/395 , C07K16/28 , A61K47/00
摘要： The present invention provides an improved pharmaceutical composition for storage and administration comprising (a) a bispecific antibody construct comprising a first domain binding to a target cell surface antigen and a second domain binding to a second antigen, wherein the bispecific antibody construct is present at a concentration in the range from about 0.5 μg/ml to 20 mg/ml, (b) a preservative at a concentration effective to inhibit the growth of microbes, and (c) a diluent wherein bispecific antibody construct is stable and recoverable.

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

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