CONTINUOUS MANUFACTURING PROCESS FOR BISPECIFIC ANTIBODY PRODUCTS

    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

    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.

    Continuous manufacturing process for bispecific antibody products

    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.

    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.

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