Industrial translation requirements for manufacture of stem cell-derived and tissue-engineered products

Ivan Wall*, David Silva Thompson, Carlotta Peticone, Roman Perez

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

The emerging regenerative medicine field has significant potential to change health care delivery in the 21st century. Primarily, stem cell culture methods and tissue engineering approaches typically adopted in biology labs are not scalable, yet scalability is key to ensuring commercial manufacturing success and delivery to clinic. An early example of how industrial translation made critical improvements to scalable production and provided near-unlimited access to a medicine is the development of penicillin. This chapter considers the challenges for manufacturing and potential solutions to deliver new tissue-engineered products to the clinic. Manufacturing scale is the appropriate scale to generate the desired amount of clinical-grade product in a cost effective way. Bioreactors have been subject to extensive investigation for bone tissue engineering. Perfusion bioreactor systems consistently yield improved osteogenic induction and maturation in mesenchymal cells. Critical quality attributes (CQAs) are not always an appropriate way of defining products due to inherent heterogeneity, particularly across multiple autologous samples.

Original languageEnglish
Title of host publicationTissue Engineering and Regeneration in Dentistry
Subtitle of host publicationCurrent Strategies
PublisherWiley-Blackwell
Pages110-123
Number of pages14
ISBN (Electronic)9781119282181
ISBN (Print)9781118741108
DOIs
Publication statusPublished - 1 Nov 2016

Keywords

  • Bone tissue engineering
  • Clinical-grade product
  • Critical quality attributes
  • Industrial translation
  • Mesenchymal cells
  • Penicillin
  • Perfusion bioreactor systems
  • Regenerative medicine
  • Stem cell culture
  • Tissue engineering

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