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：US20230194166A1

公开(公告)日：2023-06-22

申请号：US17924925

申请日：2021-05-11

Applicant: AMGEN INC.

Inventor： Christopher John Garvin ,  Fabrice Schlegel ,  Gioval Scalzo ,  Colm Bambury ,  Deniz Bac ,  Christian Ruitberg

IPC: F26B5/06 ,  F26B21/10

CPC classification number: F26B5/06 ,  F26B21/10

Abstract: A method of facilitating real-time monitoring of conditions within a vial during a lyophilization process occurring within a lyophilization chamber includes, for each of a plurality of time intervals during the lyophilization process, determining current values of temperature and pressure within the lyophilization chamber and, after each time interval, determining current values of one or more conditions within the vial. Determining the current values of the condition(s) within the vial includes applying those current values as inputs to a heat and mass transfer balance model and solving for a current value of a temperature within the vial (and possibly water removed from or remaining within the product). The method also includes causing a display device to display the current value(s) of the condition(s) within the vial to a user, and/or controlling the temperature and/or pressure within the lyophilization chamber based on the current value(s) of the condition(s) within the vial.