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    Mammalian cell culture for production of recombinant proteins: A review of the critical steps in their biomanufacturing


    O’Flaherty, Roisin and Bergin, Adam and Flampouri, Evangelia and Mota, Letícia Martins and Obaidi, Ismael and Quigley, Andrew and Xie, Yongjing and Butler, Michael (2020) Mammalian cell culture for production of recombinant proteins: A review of the critical steps in their biomanufacturing. Biotechnology Advances, 43. p. 107552. ISSN 07349750

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    Abstract

    The manufacturing of recombinant protein is traditionally undertaken in mammalian cell culture. Today, speed, cost and safety are the primary considerations for process improvements in both upstream and downstream manufacturing. Leaders in the biopharmaceutical industry are striving for continuous improvements to increase throughput, lower costs and produce safer more efficacious drugs. This can be achieved through advances in cell line engineering, process development of cell culture, development of chemically defined media and increased emphasis on product characterization. In the first part, this review provides a historical perspective on approved biotherapeutics by regulatory bodies which pave the way for next-generation products (including gene therapy). In the second part, it focuses on the application of in vitro and in vivo cell line engineering approaches, modern process development improvements including continuous manufacturing, recent developments in media formulation, and improvements in critical quality attribute determinations for products produced predominantly in mammalian cells.

    Item Type: Article
    Keywords: Mammalian cell culture; Biotherapeutics; CHO; mAbs; Recombinant proteins; Critical quality attributes; Perfusion; Fed-batch; Glycoengineering; Serum; Culture media;
    Academic Unit: Faculty of Science and Engineering > Chemistry
    Faculty of Science and Engineering > Research Institutes > Human Health Institute
    Item ID: 16172
    Identification Number: https://doi.org/10.1016/j.biotechadv.2020.107552
    Depositing User: Roisin O'Flaherty
    Date Deposited: 22 Jun 2022 07:56
    Journal or Publication Title: Biotechnology Advances
    Refereed: Yes
    URI:

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