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

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Title: Mammalian cell culture for production of recombinant proteins: A review of the critical steps in their biomanufacturing.
Authors: O'Flaherty, Róisín1 (AUTHOR), Bergin, Adam1 (AUTHOR), Flampouri, Evangelia1 (AUTHOR), Mota, Letícia Martins1 (AUTHOR), Obaidi, Ismael1,2 (AUTHOR), Quigley, Andrew1 (AUTHOR), Xie, Yongjing1 (AUTHOR), Butler, Michael1 (AUTHOR) michael.butler@nibrt.ie
Source: Biotechnology Advances. Nov2020, Vol. 43, pN.PAG-N.PAG. 1p.
Subjects: Cell culture, Cell lines, Biopharmaceutics, Gene therapy, Product attributes
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. [ABSTRACT FROM AUTHOR]
Copyright of Biotechnology Advances is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Engineering Source
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DbLabel: Engineering Source
An: 145440718
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
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  Data: 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. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Biotechnology Advances is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1016/j.biotechadv.2020.107552
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              Text: Nov2020
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