公开(公告)号：US12000915B2

公开(公告)日：2024-06-04

申请号：US17766055

申请日：2020-10-02

Applicant: AMGEN INC.

Inventor： Marc A. Caporini ,  Ron C. Kelly ,  Mariana De Maillé

IPC: G01R33/44 ,  G01N24/08

CPC classification number: G01R33/448 ,  G01N24/08

Abstract: Disclosed herein is a method of conducting direct detection 1H solid state NMR (“ssNMR”) on a macromolecule-containing solid state formulation. The method includes conducting a 1H spin-lattice relaxation time (“T1”) experiment on the solid state formulation at various temperatures to generate a T1 value at each temperature, converting the T1 values to 1H spin-lattice relaxation rate (“R1”), and plotting R1 versus temperature to generate a relaxation rate curve for the solid state formulation. The relaxation rate curve can be analyzed to determine the molecular mobility of the macromolecule in the solid state formulation, the degree of aggregation in the solid state formulation, and/or the stability of the solid state formulation.

公开(公告)号：US20240013869A1

公开(公告)日：2024-01-11

申请号：US18025311

申请日：2021-08-30

Applicant: AMGEN INC.

Inventor： Ron Christopher Kelly ,  Mary Chaves ,  Marc A. Caporini ,  Fabrice Schlegel

IPC: G16C60/00 ,  G16C20/70 ,  G16C20/80

CPC classification number: G16C60/00 ,  G16C20/70 ,  G16C20/80

Abstract: A method of computational modeling to predict stability of a lyophilized drug product includes receiving model parameters describing a virtual cake, a virtual vial, a virtual stopper, and a virtual ambient environment. The method also includes computing, by implementing a computational model and at each of a plurality of virtual time steps, a change in water amount or concentration in the virtual cake, virtual air within the virtual vial, and the virtual stopper, in part by applying the model parameters to the computational model. The method also includes generating information for display to a user via a user interface.

公开(公告)号：US11958882B2

公开(公告)日：2024-04-16

申请号：US16494165

申请日：2018-03-14

Applicant: AMGEN INC.

Inventor： Rizwan Sharnez ,  William Trieu ,  Marc A. Caporini ,  Ron C. Kelly ,  Neill Burt ,  Laura Nicholson ,  Twinkle R. Christian

IPC: C30B7/10 ,  A61K39/395 ,  B01J8/20 ,  B01J8/38 ,  C07K1/30 ,  C30B7/00 ,  C30B30/04 ,  G01N24/08 ,  C30B30/00 ,  C30B30/02 ,  G01N24/00 ,  G01R33/20 ,  G01R33/46

CPC classification number: C07K1/306 ,  A61K39/39591 ,  B01J8/20 ,  B01J8/38 ,  C30B7/00 ,  C30B7/10 ,  C30B30/04 ,  G01N24/087 ,  C30B30/00 ,  C30B30/02 ,  G01N24/00 ,  G01N24/008 ,  G01R33/20 ,  G01R33/46

Abstract: 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.

公开(公告)号：US20220365156A1

公开(公告)日：2022-11-17

申请号：US17766055

申请日：2020-10-02

Applicant: AMGEN INC.

Inventor： Marc A. Caporini ,  Ron C. Kelly ,  Mariana De Maillé

IPC: G01R33/44 ,  G01N24/08

Abstract: Disclosed herein is a method of conducting direct detection 1H solid state NMR (“ssNMR”) on a macromolecule-containing solid state formulation. The method includes conducting a 1H spin-lattice relaxation time (“T1”) experiment on the solid state formulation at various temperatures to generate a T1 value at each temperature, converting the T1 values to 1H spin-lattice relaxation rate (“R1”), and plotting R1 versus temperature to generate a relaxation rate curve for the solid state formulation. The relaxation rate curve can be analyzed to determine the molecular mobility of the macromolecule in the solid state formulation, the degree of aggregation in the solid state formulation, and/or the stability of the solid state formulation.

公开(公告)号：US20200157141A1

公开(公告)日：2020-05-21

申请号：US16494165

申请日：2018-03-14

Applicant: AMGEN INC.

Inventor： Rizwan Sharnez ,  William Trieu ,  Marc A. Caporini ,  Ron C. Kelly ,  Neill Burt ,  Laura Nicholson ,  Twinkle R. Christian

IPC: C07K1/30 ,  A61K39/395 ,  G01N24/08

Abstract: 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.