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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：US20220275073A1
公开(公告)日：2022-09-01
申请号：US17633768
申请日：2020-08-07
申请人： AMGEN INC.
发明人： Twinkle R. Christian
摘要： The present disclosure is directed to pharmaceutical compositions comprising an anti-sclerostin antibody.
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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：US09617333B2
公开(公告)日：2017-04-11
申请号：US14832268
申请日：2015-08-21
申请人： AMGEN INC.
IPC分类号： C07K16/18 , A61K39/35 , C07K16/22 , A61K39/395 , A61K39/00
CPC分类号： C07K16/18 , A61K39/39591 , A61K2039/505 , C07K16/22 , C07K2317/56 , C07K2317/76
摘要： Described herein are anti-sclerostin antibody crystals, methods of making such antibody crystals and formulations comprising the antibody crystals.
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公开(公告)号：US11773184B2
公开(公告)日：2023-10-03
申请号：US16799601
申请日：2020-02-24
申请人： AMGEN INC.
IPC分类号： C07K16/40 , A61K39/395
CPC分类号： C07K16/40 , A61K39/39591 , C07K2317/565
摘要： Described herein are anti-PCSK9 antibody crystals, methods of making such antibody crystals and formulations comprising the antibody crystals.
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公开(公告)号：US20210047407A1
公开(公告)日：2021-02-18
申请号：US16964452
申请日：2019-02-08
申请人： AMGEN INC.
发明人： Twinkle R. Christian , Daxian Shan
摘要： The present disclosure describes low pH formulations comprising, e.g., an antigen-binding protein that binds CD3, at least one buffer agent, at least one saccharide and at least one surfactant.
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公开(公告)号：US20200157141A1
公开(公告)日：2020-05-21
申请号：US16494165
申请日：2018-03-14
申请人： AMGEN INC.
发明人： Rizwan Sharnez , William Trieu , Marc A. Caporini , Ron C. Kelly , Neill Burt , Laura Nicholson , Twinkle R. Christian
IPC分类号： C07K1/30 , A61K39/395 , G01N24/08
摘要： Disclosed herein are methods of preparing a composition comprising crystalline biomolecules, for example, crystalline antibodies. In exemplary embodiments, the method comprises forming a fluidized bed of crystalline biomolecules using, for example, a counter-flow centrifuge to exchange buffer and/or to concentrate the crystalline biomolecules in a solution. Also provided are methods of detecting crystalline biomolecules and/or amorphous biomolecules in a sample.
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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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公开(公告)号：US11459401B2
公开(公告)日：2022-10-04
申请号：US16337325
申请日：2017-10-06
申请人： AMGEN INC.
发明人： Alona Teran , Qahera Munaim , Nazer Khalaf , Rahul Rajan Kaushik , Christi L. Clogston , Twinkle R. Christian , William J. Callahan
IPC分类号： A61K39/395 , C07K16/40 , A61K9/19 , A61K47/18 , A61K47/22 , A61K47/24 , A61K47/26 , A61K47/42
摘要： Described herein are therapeutic protein formulations comprising N-methyl pyrrolidone (NMP), methods related to reducing viscosity of pharmaceutical formulations and methods related to stabilizing pharmaceutical formulations using NMP.
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