公开(公告)号：US12251474B2

公开(公告)日：2025-03-18

申请号：US16652667

申请日：2018-09-10

Applicant: AMGEN INC.

Inventor： Clea Talley

IPC: A61K9/19 ,  A61K38/19 ,  A61K39/395 ,  A61K47/02 ,  A61K47/10 ,  A61K47/18 ,  A61K47/22 ,  A61K47/26 ,  A61K47/40 ,  C07K14/52 ,  C07K16/28 ,  C07K16/32

Abstract: This invention concerns a process for making a lyophilized pharmaceutical formulation of a therapeutic protein, which comprises (a) providing a formulation of a bulk amount of the therapeutic protein, (b) measuring the concentration of the therapeutic protein in said bulk formulation, (c) adjusting the fill weight of the protein in said bulk formulation to achieve a fixed dose of the protein, and (d) lyophilizing the protein fill weight-adjusted formulation to achieve a final formulation in a container, wherein the product concentration post reconstitution with a fixed volume is within a predetermined acceptance range. The process is particularly suitable for formulations with low protein concentrations (e.g., 0.05 mg/mL to 20 mg/mL).

公开(公告)号：US20210163531A1

公开(公告)日：2021-06-03

申请号：US17046662

申请日：2019-03-28

Applicant: AMGEN INC.

Inventor： William Callahan ,  Lorenzo Desantiago ,  Clea Talley ,  Yael Wexler-Cohen ,  Jeffrey Abel ,  Rahul Kaushik ,  Nitya Mariam Jacob ,  Carson Tran ,  Nicole Ball ,  Monica Goss

IPC: C07K1/36 ,  C07K1/34 ,  C07K1/18 ,  C07K1/16 ,  C07K16/28 ,  C07K16/30 ,  C07K14/535 ,  C07K14/505 ,  C07K14/71 ,  C07K14/715 ,  C07K16/40 ,  C07K16/32 ,  C07K16/22 ,  C07K16/18

Abstract: The invention relates to methods for preparing stable buffered and buffer-free protein compositions. The invention also relates to methods of purifying proteins from one or more impurities.