公开(公告)号：US20210163592A1

公开(公告)日：2021-06-03

申请号：US16770441

申请日：2018-12-11

Applicant: AMGEN INC

Inventor： Chetan Goudar ,  Rohini Deshpande ,  Natalia Gomez ,  Hedieh Barkhordarian ,  Yan Wang

IPC: C07K16/28 ,  C07K16/30

Abstract: The present invention provides a continuous upstream manufacturing process for the production of bispecific antibody products, which comprise at least two binding domains. The process comprises at least the steps of (i) providing in a perfusion bioreactor at least one mammalian cell culture, which is capable of expressing the bispecific antibody product, (ii) growing the mammalian cell culture at a first perfusion rate until a set point viable cell density is reached, and (iii) maintaining perfusion culture at a second perfusion rate, wherein the bispecific antibody product concentration in the bioreactor is kept below a threshold value. The bispecific antibody product is then subject to subsequent downstream processing. Moreover, the invention provides a bispecific antibody product produced by the continuous upstream manufacturing process.

公开(公告)号：US12227571B2

公开(公告)日：2025-02-18

申请号：US16770441

申请日：2018-12-11

Applicant: AMGEN INC.

Inventor： Chetan Goudar ,  Rohini Deshpande ,  Natalia Gomez ,  Hedieh Barkhordarian ,  Yan Wang

IPC: C07K16/28 ,  C07K16/30 ,  C12M1/00 ,  C12N5/00 ,  B01F101/44 ,  C12M3/00

Abstract: The present invention provides a continuous upstream manufacturing process for the production of bispecific antibody products, which comprise at least two binding domains. The process comprises at least the steps of (i) providing in a perfusion bioreactor at least one mammalian cell culture, which is capable of expressing the bispecific antibody product, (ii) growing the mammalian cell culture at a first perfusion rate until a set point viable cell density is reached, and (iii) maintaining perfusion culture at a second perfusion rate, wherein the bispecific antibody product concentration in the bioreactor is kept below a threshold value. The bispecific antibody product is then subject to subsequent downstream processing. Moreover, the invention provides a bispecific antibody product produced by the continuous upstream manufacturing process.