Journal
REGENERATIVE MEDICINE
Volume 7, Issue 1, Pages 71-84Publisher
FUTURE MEDICINE LTD
DOI: 10.2217/RME.11.101
Keywords
automation; large scale; microcarriers; pluripotent stem cells; scale-out; scale-up; separation; suspension culture
Categories
Funding
- Biotechnology and Biological Sciences Research Council (BBSRC
- UK) Bioprocessing Research Industries Club (BRIC)
- BBSRC [BB/G010404/1] Funding Source: UKRI
- EPSRC [EP/H028277/1] Funding Source: UKRI
- Biotechnology and Biological Sciences Research Council [BB/G010404/1] Funding Source: researchfish
- Engineering and Physical Sciences Research Council [EP/H028277/1] Funding Source: researchfish
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Human pluripotent stem cells will likely be a significant part of the regenerative medicine-driven healthcare revolution. In order to realize this potential, culture processes must be standardized, scalable and able to produce clinically relevant cell numbers, whilst maintaining critical biological functionality. This review comprises a broad overview of important bioprocess considerations, referencing the development of biopharmaceutical processes in an effort to learn from current best practice in the field. Particular focus is given to the recent efforts to grow human pluripotent stem cells in microcarrier or aggregate suspension culture, which would allow geometric expansion of productive capacity were it to be fully realized. The potential of these approaches is compared with automation of traditional T-flask culture, which may provide a cost-effective platform for low-dose, low-incidence conditions or autologous therapies. This represents the first step in defining the full extent of the challenges facing bioprocess engineers in the exploitation of large-scale human pluripotent stem cell manufacture.
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