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公开(公告)号：US20220396599A1
公开(公告)日：2022-12-15
申请号：US17775386
申请日：2020-11-13
Applicant: AMGEN INC.
Inventor： Yan Wang , Nicholas Marchand , Robert Perry Brake , Maria Perry , Ashish Sharma , Eugene Sun
Abstract: The present disclosure provides a downstream manufacturing method for the production of bispecific antigen-binding molecule products, which comprise at least two different binding domains. The process comprises at least one filtration step, wherein the filtration is ultrafiltration/diafiltration (UF/DF), and/or viral filtration (VF), wherein a β-cyclodextrin is applied in the process either in a buffer applied in the filtration step or added to the filtration pool after the UF/DF filtration step wherein the buffer or the pool have a concentration of about 0.1 to 3% (m/v) of a (3-cyclodextrin, to preferably keep the product in a non-aggregated form.
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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
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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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
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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