公开(公告)号：US20240374720A1

公开(公告)日：2024-11-14

申请号：US17928561

申请日：2021-05-28

Applicant: Amgen Inc.

Inventor： Anna IP ,  Ketaki PATEL ,  Clea TALLEY ,  Michael J. TREUHEIT ,  Jun ZHANG

IPC: A61K39/395 ,  A61K47/12 ,  A61K47/18 ,  A61K47/26 ,  C07K16/18

Abstract: Antibody formulations and methods of making and using such formulations are provided herein. The formulation can be for intravenous administration. In some embodiments, the formulation is for subcutaneous administration. In some embodiments, the formulation comprises an anti-C5 antibody, such as eculizumab.

公开(公告)号：US20210369616A1

公开(公告)日：2021-12-02

申请号：US16652667

申请日：2018-09-10

Applicant: AMGEN INC.

Inventor： Clea TALLEY

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

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：US20190083402A1

公开(公告)日：2019-03-21

申请号：US16127123

申请日：2018-09-10

Applicant: AMGEN INC.

Inventor： Clea TALLEY

IPC: A61K9/19 ,  A61K38/19 ,  C07K16/28 ,  A61K47/02 ,  C07K14/52

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 to 20 mg/mL).