公开(公告)号：US12103979B2

公开(公告)日：2024-10-01

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: A61K39/395 ,  A61K9/08 ,  A61K9/19 ,  A61K31/198 ,  A61K31/401 ,  A61K31/4172 ,  A61K38/05 ,  A61K47/18 ,  A61K47/26 ,  C07K5/06 ,  C07K16/18 ,  C07K16/40

CPC classification number: C07K16/40 ,  A61K9/08 ,  A61K9/19 ,  A61K31/198 ,  A61K31/401 ,  A61K31/4172 ,  A61K38/05 ,  A61K39/3955 ,  A61K39/39591 ,  A61K47/183 ,  A61K47/26 ,  C07K5/06 ,  C07K16/18

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.

公开(公告)号：US08980256B2

公开(公告)日：2015-03-17

申请号：US13678407

申请日：2012-11-15

Applicant: Amgen Inc.

Inventor： Tiansheng Li ,  Christopher James Sloey

IPC: A61K39/00 ,  C07K16/00 ,  A61K9/19 ,  A61K47/10 ,  A61K9/00 ,  A61K38/18 ,  A61K38/19 ,  A61K39/395 ,  A61K47/02 ,  A61K47/18 ,  A61K47/26

CPC classification number: A61K47/10 ,  A61K9/0019 ,  A61K9/19 ,  A61K38/1816 ,  A61K38/193 ,  A61K39/39533 ,  A61K39/39591 ,  A61K47/02 ,  A61K47/18 ,  A61K47/183 ,  A61K47/186 ,  A61K47/26 ,  A61K2039/505

Abstract: A method of stabilizing an aqueous protein or antibody formulation is disclosed herein. Additionally, stable pharmaceutical formulations are contemplated which comprise a biologically active protein, a destabilizing concentration of preservative and a stabilizing concentration of osmolyte.

Abstract translation: 本文公开了稳定水性蛋白质或抗体制剂的方法。 此外，涵盖稳定的药物制剂，其包含生物活性蛋白质，去稳定浓度的防腐剂和稳定的渗透液浓度。

公开(公告)号：US20130121990A1

公开(公告)日：2013-05-16

申请号：US13742818

申请日：2013-01-16

Applicant: Amgen Inc.

Inventor： Christopher James Sloey ,  Camille Vergara ,  Jason Ko ,  Tiansheng Li

IPC: A61K47/22 ,  A61K47/18

CPC classification number: A61K47/24 ,  A61K9/0019 ,  A61K9/19 ,  A61K39/395 ,  A61K47/18 ,  A61K47/183 ,  A61K47/186 ,  A61K47/22

Abstract: A stable pharmaceutical formulation is provided that comprises a biologically active protein and an excipient selected from carnitine, creatine or creatinine.

Abstract translation: 提供了稳定的药物制剂，其包含生物活性蛋白质和选自肉碱，肌酸或肌酸酐的赋形剂。

公开(公告)号：US20230126688A1

公开(公告)日：2023-04-27

申请号：US17929232

申请日：2022-09-01

Applicant: AMGEN INC.

Inventor： Christopher James Sloey ,  Jason Ko ,  Tiansheng Li

IPC: A61K47/12 ,  A61K47/22 ,  A61K39/395 ,  A61K9/00 ,  A61K38/18

Abstract: The present invention relates to stable aqueous protein formulations. In particular, disclosed herein are therapeutic protein formulations suitable for parenteral administration having one or more antioxidants.

公开(公告)号：US10668154B2

公开(公告)日：2020-06-02

申请号：US14613501

申请日：2015-02-04

Applicant: AMGEN INC.

Inventor： Tiansheng Li ,  Christopher James Sloey

IPC: A61K38/18 ,  A61K9/14 ,  C07K14/475 ,  C07K1/30 ,  A61K47/10 ,  A61K39/395 ,  A61K9/00 ,  A61K9/19 ,  A61K38/19 ,  A61K47/02 ,  A61K47/18 ,  A61K47/26 ,  A61K39/00

Abstract: A method of stabilizing an aqueous protein or antibody formulation is disclosed herein. Additionally, stable pharmaceutical formulations are contemplated which comprise a biologically active protein, a destabilizing concentration of preservative and a stabilizing concentration of osmolyte.

公开(公告)号：US09320797B2

公开(公告)日：2016-04-26

申请号：US13742818

申请日：2013-01-16

Applicant: AMGEN INC.

Inventor： Christopher James Sloey ,  Camille Vergara ,  Jason Ko ,  Tiansheng Li

IPC: A61K39/395 ,  A61K47/22 ,  A61K9/19 ,  A61K47/18 ,  A61K9/00

CPC classification number: A61K47/24 ,  A61K9/0019 ,  A61K9/19 ,  A61K39/395 ,  A61K47/18 ,  A61K47/183 ,  A61K47/186 ,  A61K47/22

Abstract: A stable pharmaceutical formulation is provided that comprises a biologically active protein and an excipient selected from carnitine, creatine or creatinine.

公开(公告)号：US11464857B2

公开(公告)日：2022-10-11

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

IPC: A61K39/395 ,  C07K16/40 ,  A61K47/18 ,  C07K1/36 ,  A61K9/00 ,  C07K1/16 ,  C07K16/06 ,  C07K16/22

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.

公开(公告)号：US20200276313A1

公开(公告)日：2020-09-03

申请号：US16878385

申请日：2020-05-19

Applicant: AMGEN INC.

Inventor： Christopher James Sloey ,  Camille Vergara ,  Jason Ko ,  Tiansheng Li

IPC: A61K47/24 ,  A61K9/19 ,  A61K47/18 ,  A61K47/22 ,  A61K39/395

Abstract: A stable pharmaceutical formulation is provided that comprises a biologically active protein and an excipient selected from caritine, creatine or creatinine.

公开(公告)号：US20150335748A1

公开(公告)日：2015-11-26

申请号：US14613501

申请日：2015-02-04

Applicant: Amgen Inc.

Inventor： Tiangsheng LI ,  Christopher James Sloey

IPC: A61K47/10 ,  A61K39/395

Abstract: A method of stabilizing an aqueous protein or antibody formulation is disclosed herein. Additionally, stable pharmaceutical formulations are contemplated which comprise a biologically active protein, a destabilizing concentration of preservative and a stabilizing concentration of osmolyte.

Abstract translation: 本文公开了稳定水性蛋白质或抗体制剂的方法。 此外，涵盖稳定的药物制剂，其包含生物活性蛋白质，去稳定浓度的防腐剂和稳定的渗透液浓度。

公开(公告)号：US20130071387A1

公开(公告)日：2013-03-21

申请号：US13678407

申请日：2012-11-15

Applicant: AMGEN INC.

Inventor： Tiansheng LI ,  Christopher James Sloey

IPC: A61K47/10

CPC classification number: A61K47/10 ,  A61K9/0019 ,  A61K9/19 ,  A61K38/1816 ,  A61K38/193 ,  A61K39/39533 ,  A61K39/39591 ,  A61K47/02 ,  A61K47/18 ,  A61K47/183 ,  A61K47/186 ,  A61K47/26 ,  A61K2039/505

Abstract: A method of stabilizing an aqueous protein or antibody formulation is disclosed herein. Additionally, stable pharmaceutical formulations are contemplated which comprise a biologically active protein, a destabilizing concentration of preservative and a stabilizing concentration of osmolyte.

Abstract translation: 本文公开了稳定水性蛋白质或抗体制剂的方法。 此外，涵盖稳定的药物制剂，其包含生物活性蛋白质，去稳定浓度的防腐剂和稳定的渗透液浓度。