Commercial manufacture of cell therapies

I. B. Wall*, D. A. Brindley

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

The commercial manufacture of cell-based therapies is expected to revolutionise healthcare provision over the coming decades and address growing clinical needs of an aging population and associated age-related degenerative disorders. Exciting advances in the emerging field of stem cell biology have great potential to treat many of these diseases. This chapter provides an overview of the challenges of moving from a laboratory-scale experiment to regulatorily sound industrial manufacturing platforms. The adoption of standardised protocols to attain a clearly defined, high-quality product across multiple batches is essential, as is the capacity for scale-up processing for allogeneic cell therapy or scale-out processing for autologous therapy.

Original languageEnglish
Title of host publicationStandardisation in Cell and Tissue Engineering
Subtitle of host publicationMethods and Protocols
PublisherElsevier
Pages212-239
Number of pages28
ISBN (Print)9780857094193
DOIs
Publication statusPublished - 1 Jan 2013

Keywords

  • Bottlenecks
  • Cell therapy
  • Clinical trials
  • Commercialisation
  • Manufacturing
  • Platform process
  • Regenerative medicine
  • Scale-up

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