The Scale-up of Human Mesenchymal Stem Cell Expansion and Recovery

Thomas R.J. Heathman*, Qasim A. Rafiq, Karen Coopman, Alvin W. Nienow, Christopher J. Hewitt

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Science and medicine has revealed the potential of cell therapies; however, for this to be realised, scalable and robust manufacturing processes must be developed for the reproducible production of clinically-relevant numbers of fully functional stem cells. It is well established that for all products made either by cell culture or fermentation, the process must be defined with equally defined critical quality attributes (CQAs) that can be monitored and controlled to ensure product safety as well as efficacy. Human mesenchymal stem cells need to be attached to a surface to grow and cannot be adapted to suspension culture. For allogeneic cell therapy processes, scale-up approaches are more likely to be employed. As well as the physical challenge of removing the cells from the microcarriers, there remains a challenge in demonstrating comparability of cell CQAs with the monolayer process, which will be essential to effectively scale up the process.

Original languageEnglish
Title of host publicationBioprocessing for Cell Based Therapies
PublisherWiley-Blackwell
Pages91-125
Number of pages35
ISBN (Electronic)9781118743362
ISBN (Print)9781118743416
DOIs
Publication statusPublished - 16 Dec 2016

Keywords

  • Cell culture
  • Cell therapies
  • Critical quality attributes
  • Human mesenchymal stem cells
  • Scale-up approaches
  • Science fields

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    Heathman, T. R. J., Rafiq, Q. A., Coopman, K., Nienow, A. W., & Hewitt, C. J. (2016). The Scale-up of Human Mesenchymal Stem Cell Expansion and Recovery. In Bioprocessing for Cell Based Therapies (pp. 91-125). Wiley-Blackwell. https://doi.org/10.1002/9781118743362.ch4