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Production of Recombinant Therapeutic Proteins by Mammalian Cells in Suspension Culture

  • Protocol
Therapeutic Proteins

Part of the book series: Methods in Molecular Biology™ ((MIMB,volume 308))

Abstract

Within the past 10 yr, 17 monoclonal antibodies (MAbs) have been approved in the United States. A survey of these approved MAbs reveals that the predominant platform is a serum-free, stirred-tank mammalian cell culture. In fact, all 17 products are grown in only four cell lines: Chinese hamster ovary (CHO) cells, mouse myeloma cells (NS0 and Sp2/0), or hybridoma cells. The trend toward platform consolidation enables the possibility to quicken process development timelines to establish a common method in the development of a large-scale production process. This chapter will outline the general format for producing a recombinant protein in stirred tank, serumfree cultures beginning from a recombinant plasmid and a mammalian host cell line. Although different cell lines are used in this chapter as examples for the various methods, these methods are applicable across most common production cell lines. The purification options following harvest of the bulk material are not discussed, nor are the details of regulatory requirements, but purification information is readily available in other chapters of this book, and regulatory guidance documents are available at the regulatory websites, such as http://www.fda.gov/cber and http://www.ich.org.

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Author information

Authors and Affiliations

  1. Merck & Co., Inc., Rahway, NJ

    Lily Chu, Ilse Blumentals & Gargi Maheshwari

Authors
  1. Lily Chu
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  2. Ilse Blumentals
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  3. Gargi Maheshwari
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Editor information

Editors and Affiliations

  1. Protein Science Group, Department of Biosciences, University of Kent, Canterbury, Kent, UK

    C. Mark Smales

  2. School of Engineering, University of Queensland, St. Lucia, Queensland, Australia

    David C. James

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© 2005 Humana Press Inc.

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Chu, L., Blumentals, I., Maheshwari, G. (2005). Production of Recombinant Therapeutic Proteins by Mammalian Cells in Suspension Culture. In: Smales, C.M., James, D.C. (eds) Therapeutic Proteins. Methods in Molecular Biology™, vol 308. Humana Press. https://doi.org/10.1385/1-59259-922-2:107

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  • DOI: https://doi.org/10.1385/1-59259-922-2:107

  • Publisher Name: Humana Press

  • Print ISBN: 978-1-58829-390-9

  • Online ISBN: 978-1-59259-922-6

  • eBook Packages: Springer Protocols

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