Abstract
Human induced pluripotent stem cells (iPSCs), since their discovery in 2007, have rapidly become a starting cell type of choice for the differentiation of many mature cell types. Their flexibility, amenability to gene editing and functional equivalence to embryonic stem cells ensured their subsequent adoption by many manufacturing processes for cellular products. In this chapter, we will discuss the process whereby iPSCs are generated, key quality control steps which should be considered during manufacturing, the application of good manufacturing practice to production processes and iPSC-derived cellular products which are already undergoing clinical trials. iPSCs provide a new avenue for the next generation of cellular therapeutics and by combining new differentiation protocols, quality control and reproducible manufacturing, iPSC-derived cellular products could provide treatments for many currently untreatable diseases, allowing the large-scale manufacture of high-quality cell therapies.
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Acknowledgements
I would like to thank Emma Lawrence for proofreading, editing, and regulatory advice. Thank you also to Charlotte Flahou for clinical trial information and David Cyranoski for proofreading.
I am very grateful to the Japanese Society for the Promotion of Science (JSPS) for funding my research (PE21019), Prof. Takuya Yamamoto for his supervision, support, and mentorship, and all my colleagues at the Centre for iPS Cell Research and Application (CiRA) and the Institute for the Advanced Study of Human Biology (ASHBi), Kyoto University, Japan.
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Lawrence, M. (2023). Human iPS Cells for Clinical Applications and Cellular Products. In: Kuehn, M.H., Zhu, W. (eds) Human iPSC-derived Disease Models for Drug Discovery. Handbook of Experimental Pharmacology, vol 281. Springer, Cham. https://doi.org/10.1007/164_2023_643
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