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公开(公告)号：US20230167175A1
公开(公告)日：2023-06-01
申请号：US17921793
申请日：2021-04-28
申请人： AMGEN INC.
CPC分类号： C07K16/2809 , C07K16/2803 , C07K16/30 , C07K16/2863 , C07K16/2878 , C07K16/2875 , C07K16/28 , A61K47/183 , A61K47/26 , C07K2317/622 , C07K2317/31
摘要： The present disclosure describes stable aqueous formulations comprising, e.g., a bispecific antibody construct, a buffer, a saccharide and a surfactant, the formulation having a pH 4.8-5.5.
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公开(公告)号：US20230310324A1
公开(公告)日：2023-10-05
申请号：US18024893
申请日：2021-09-14
申请人： AMGEN INC.
CPC分类号： A61K9/19 , A61K47/26 , A61K47/183 , C07K16/2863 , C07K2317/31
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.
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公开(公告)号：US20230348596A1
公开(公告)日：2023-11-02
申请号：US18022685
申请日：2021-08-23
申请人： AMGEN INC.
CPC分类号： C07K16/2809 , A61K47/20 , A61K47/26 , A61K47/183 , A61K9/19 , C07K16/3069 , C07K16/28 , C07K16/2803 , C07K16/2851 , C07K16/2878 , C07K16/30 , C07K2317/31 , C07K2317/94
摘要： The disclosure provides a formulation comprising, e.g., a bispecific antibody construct, a buffer, a saccharide, a surfactant, and methionine.
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公开(公告)号：US20200332000A1
公开(公告)日：2020-10-22
申请号：US16482603
申请日：2018-02-02
发明人： Arnold Mcauley , Pavan Ghattyvenkatakrishna , Jeff Abel , Joon Huh , Cornelius Pompe , Sekhar Kanapuram , Michael Treuheit , Bharadwaj Jagannathan
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.
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5.发明申请公开(公告)号：US20190151448A1
公开(公告)日：2019-05-23
申请号：US15972489
申请日：2018-05-07
申请人： AMGEN INC.
发明人： Jeff Abel , Lingwen Cui , Devrishi Goswami , Joon Huh , Bharadwaj Jagannathan , Sekhar Kanapuram , Arnold McAuley , Michael Schneider , Ananthakrishnan G. Sethuraman , Michael Treuheit , Jun Zhang
IPC分类号： A61K39/395 , C07K16/28 , A61K47/10 , A61K47/14 , A61K47/24 , A61K47/12 , A61K47/26 , A61K47/18 , C07K16/46
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.
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公开(公告)号：US20240336685A1
公开(公告)日：2024-10-10
申请号：US17281896
申请日：2019-09-27
申请人： AMGEN INC.
IPC分类号： C07K16/28
CPC分类号： C07K16/2809 , C07K16/2803 , C07K16/2878 , C07K2317/10 , C07K2317/31
摘要： The invention disclosed herein relates to methods for reducing aggregation of bispecific antibodies, for example reducing aggregation of bispecific T cell engager (BiTE) antibody constructs, resulting from storage under frozen conditions by holding the antibodies at certain temperatures after thaw.
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公开(公告)号：US11918650B2
公开(公告)日：2024-03-05
申请号：US15972489
申请日：2018-05-07
申请人： AMGEN INC.
发明人： Jeff Abel , Lingwen Cui , Devrishi Goswami , Joon Huh , Bharadwaj Jagannathan , Sekhar Kanapuram , Arnold McAuley , Michael Schneider , Ananthakrishnan G. Sethuraman , Michael Treuheit , Jun Zhang
IPC分类号： A61K39/395 , A61K9/00 , A61K9/08 , A61K9/19 , A61K47/10 , A61K47/12 , A61K47/14 , A61K47/18 , A61K47/24 , A61K47/26 , C07K16/28 , C07K16/46 , A61J1/05 , A61J1/10 , A61K39/00
CPC分类号： A61K39/39591 , A61K9/0019 , A61K9/08 , A61K9/19 , A61K39/3955 , A61K47/10 , A61K47/12 , A61K47/14 , A61K47/183 , A61K47/24 , A61K47/26 , C07K16/2803 , C07K16/2809 , C07K16/2863 , C07K16/468 , A61J1/05 , A61J1/10 , A61K2039/54 , A61K2039/545 , A61K2039/627 , C07K2317/24 , C07K2317/31 , C07K2317/41 , C07K2317/569
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.
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公开(公告)号：US20230167176A1
公开(公告)日：2023-06-01
申请号：US17921794
申请日：2021-04-28
申请人： AMGEN INC.
CPC分类号： C07K16/2809 , C07K16/2803 , C07K16/30 , C07K16/2863 , C07K16/2878 , C07K16/2875 , C07K16/28 , A61K47/183 , A61K47/26 , C07K2317/31 , C07K2317/622
摘要： Described herein are stable high concentration bispecific antibody construct formulations, wherein the formulations have less than 2% high molecular weight species of the bispecific antibody construct in the formulation under storage conditions at various time points.
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公开(公告)号：US20220362104A1
公开(公告)日：2022-11-17
申请号：US17770355
申请日：2020-10-23
发明人： Cornelius Pompe , Nicholas J. Clark , Wei Qi , Arnold J. McAuley , MIchael Schneider , Chia-Jung Wu , Twinkle R. Christian , Heather N. Franey , Bharadwaj Jagannathan , Jeffrey Abel , Franz Dietzel
摘要： An approach for determining material compatibility for components of a drug delivery system is provided that includes using surface zeta-potential analytical method to evaluate surface interactions between a desired molecule and at least one material present within a given IV-bag system.
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