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Quality control and validation

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Safety in Cell and Tissue Culture

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Abstract

There is increasing acceptance and utilization of human and animal cell lines for the manufacture of biologicals. Continuous cell lines offer more ethically acceptable and reproducible means of production in comparison with the use of animals and primary cells. Furthermore, mammalian cell lines have the potential to provide complex recombinant biologicals with post-translational modifications (i.e. glycosylation) which are typical of native glycoproteins. The proven capabilites of 10000–1 systems has demonstrated that cell culture can be used in industrial-scale operations [1]. In regulatory matters there is a developing trend for emphasis to be placed on defining and validating the end product, rather than all constituents of the production process. This may enable the use of a wider variety of cell lines, thus increasing the opportunities to enhance productivity.

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Author information

Authors and Affiliations

  1. European Collection of Cell Cultures, Centre for Applied Microbiology and Research, Porton Down, Wiltshire, UK

    Alan Doyle

  2. National Institute for Biological Standards and Control, South Mimms, UK

    Glyn Stacey

Authors
  1. Alan Doyle
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  2. Glyn Stacey
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Editor information

Editors and Affiliations

  1. National Institute for Biological Standards and Control, South Mimms, Hertfordshire, UK

    G. Stacey

  2. Centre for Applied Microbiology and Research, European Collection of Cell Cultures, Salisbury, Wiltshire, UK

    A. Doyle

  3. Centre for Applied Microbiology and Research, Salisbury, Wiltshire, UK

    P. Hambleton

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© 1998 Springer Science+Business Media Dordrecht

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Doyle, A., Stacey, G. (1998). Quality control and validation. In: Stacey, G., Doyle, A., Hambleton, P. (eds) Safety in Cell and Tissue Culture. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-4916-7_6

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  • DOI: https://doi.org/10.1007/978-94-011-4916-7_6

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-6061-5

  • Online ISBN: 978-94-011-4916-7

  • eBook Packages: Springer Book Archive

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