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公开(公告)号:US20200048367A1
公开(公告)日:2020-02-13
申请号:US16607673
申请日:2018-04-27
Applicant: AMGEN INC.
Inventor: Neeraj Jagdish AGRAWAL , Pavan GHATTYVENKATAKRISHNA , Sekhar KANAPURAM , Christopher James SLOEY
IPC: C07K16/40 , A61K38/05 , A61K31/198 , A61K31/4172 , A61K31/401 , A61K47/26 , A61K9/08 , A61K9/19
Abstract: Provided herein are excipients capable of effectively reducing the viscosity of polypeptide (e.g., therapeutic polypeptide) formulations. The viscosity reducing excipients are dipeptides containing arginine at the carboxy terminus and N-acetylated serine or N-acetylated proline at the N-terminus. Glutamate-arginine is also disclosed as a viscosity-reducing dipeptide. Among the disclosed methods, methods of reducing the viscosities of such formulations are also provided.
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公开(公告)号:US20240409611A1
公开(公告)日:2024-12-12
申请号:US18817735
申请日:2024-08-28
Applicant: Amgen Inc.
Inventor: Yael WEXLER-COHEN , Robert Matthew FESINMEYER , Monica Michelle GOSS , Sekhar KANAPURAM , Rahul Rajan KAUSHIK , Sai Chakradhar PADALA
Abstract: VEGFR-Fc fusion protein formulations and methods of making using such formulations are provided herein. In one embodiment, the formulation is an ophthalmic formulation, such as for intravitreal administration. In some embodiments, the VEGFR-Fc fusion protein is aflibercept.
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3.
公开(公告)号:US20180237501A1
公开(公告)日:2018-08-23
申请号:US15902775
申请日:2018-02-22
Applicant: AMGEN INC.
Inventor: Christopher James SLOEY , Sekhar KANAPURAM , Huanchun CUI , Chio Mui CHAN , Elaheh BINABAJI
CPC classification number: C07K16/065 , A61K9/0019 , A61K39/3955 , A61K39/39591 , A61K47/183 , C07K1/16 , C07K1/36 , C07K16/22 , C07K16/40 , C07K2317/565 , C07K2317/76 , C07K2317/90
Abstract: Provided herein are formulations of PCSK9-binding polypeptides, such as those comprising evolocumab, that comprise N-acetyl arginine and have reduced viscosities when compared to formulations lacking N-acetyl arginine. Provided herein are also methods of formulating such compositions that are advantageous in that they conserve certain components. Such formulations comprising PCSK9-binding polypeptides can be administered to patients to treat and/or prevent PCSK9-related diseases, conditions, and disorders.
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公开(公告)号:US20240066124A1
公开(公告)日:2024-02-29
申请号:US18383121
申请日:2023-10-24
Applicant: AMGEN INC.
Inventor: Christopher James SLOEY , Sekhar KANAPURAM
IPC: A61K39/395 , A61K9/19 , A61K47/18
CPC classification number: A61K39/39591 , A61K9/19 , A61K39/3955 , A61K47/183 , A61K9/0019
Abstract: A method for reducing the viscosity of a pharmaceutical formulation is provided that utilizes a viscosity-reducing concentration of an excipient selected from the group consisting of the n-acetyl arginine, n-acetyl lysine, n-acetyl proline and mixtures thereof in combination with a therapeutiv protein. A stable pharmaceutical formulation is also provided.
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5.
公开(公告)号:US20230226177A1
公开(公告)日:2023-07-20
申请号:US17893515
申请日:2022-08-23
Applicant: AMGEN INC.
Inventor: Christopher James SLOEY , Sekhar KANAPURAM , Huanchun CUI , Chio Mui CHAN , Elaheh BINABAJI
CPC classification number: A61K39/3955 , A61K9/0019 , A61K39/39591 , A61K47/183 , C07K1/16 , C07K1/36 , C07K16/40 , C07K16/065
Abstract: Provided herein are formulations of PCSK9-binding polypeptides, such as those comprising evolocumab, that comprise N-acetyl arginine and have reduced viscosities when compared to formulations lacking N-acetyl arginine. Provided herein are also methods of formulating such compositions that are advantageous in that they conserve certain components. Such formulations comprising PCSK9-binding polypeptides can be administered to patients to treat and/or prevent PCSK9-related diseases, conditions, and disorders.
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公开(公告)号:US20230025418A1
公开(公告)日:2023-01-26
申请号:US17932255
申请日:2022-09-14
Applicant: Amgen Inc.
Inventor: Yael WEXLER-COHEN , Robert Matthew FESINMEYER , Monica Michelle GOSS , Sekhar KANAPURAM , Rahul Rajan KAUSHIK , Sai Chakradhar PADALA
Abstract: VEGFR-Fc fusion protein formulations and methods of making using such formulations are provided herein. In one embodiment, the formulation is an ophthalmic formulation, such as for intravitreal administration. In some embodiments, the VEGFR-Fc fusion protein is aflibercept.
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公开(公告)号:US20200255496A1
公开(公告)日:2020-08-13
申请号:US16647902
申请日:2018-09-17
Applicant: Amgen Inc.
Inventor: Yael WEXLER-COHEN , Robert Matthew FESINMEYER , Monica Michelle GOSS , Sekhar KANAPURAM , Rahul Rajan KAUSHIK , Sai Chakradhar PADALA
Abstract: VEGFR-Fc fusion protein formulations and methods of making using such formulations are provided herein. In one embodiment, the formulation is an ophthalmic formulation, such as for intravitreal administration. In some embodiments, the VEG-FR-Fc fusion protein is aflibercept.
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公开(公告)号:US20170333559A1
公开(公告)日:2017-11-23
申请号:US15521057
申请日:2015-10-22
Applicant: AMGEN INC.
Inventor: Christopher James SLOEY , Sekhar KANAPURAM
IPC: A61K39/395 , A61K47/18 , A61K9/19 , A61K9/00
CPC classification number: A61K39/39591 , A61K9/0019 , A61K9/19 , A61K39/3955 , A61K47/183 , C07K2317/90
Abstract: A method for reducing the viscosity of a pharmaceutical formulation is provided that utilizes a viscosity-reducing concentration of an excipient selected from the group consisting of the n-acetyl arginine, n-acetyl lysine, n-acetyl proline and mixtures thereof in combination with a therapeutiv protein. A stable pharmaceutical formulation is also provided.
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