Induced pluripotency in the context of stem cell expansion bioprocess development, optimization, and manufacturing: a roadmap to the clinic

Abstract The translation of laboratory-scale bioprocess protocols and technologies to industrial scales and the application of human induced pluripotent stem cell (hiPSC) derivatives in clinical trials globally presents optimism for the future of stem-cell products to impact healthcare. However, whi...

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Autores principales:	James Colter, Kartikeya Murari, Jeff Biernaskie, Michael Scott Kallos
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R
Acceso en línea:	https://doaj.org/article/22bb2828f64c4c59b3fd201b40927c1f
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spelling	oai:doaj.org-article:22bb2828f64c4c59b3fd201b40927c1f2021-11-08T11:15:41ZInduced pluripotency in the context of stem cell expansion bioprocess development, optimization, and manufacturing: a roadmap to the clinic10.1038/s41536-021-00183-72057-3995https://doaj.org/article/22bb2828f64c4c59b3fd201b40927c1f2021-11-01T00:00:00Zhttps://doi.org/10.1038/s41536-021-00183-7https://doaj.org/toc/2057-3995Abstract The translation of laboratory-scale bioprocess protocols and technologies to industrial scales and the application of human induced pluripotent stem cell (hiPSC) derivatives in clinical trials globally presents optimism for the future of stem-cell products to impact healthcare. However, while many promising therapeutic approaches are being tested in pre-clinical studies, hiPSC-derived products currently account for a small fraction of active clinical trials. The complexity and volatility of hiPSCs present several bioprocessing challenges, where the goal is to generate a sufficiently large, high-quality, homogeneous population for downstream differentiation—the derivatives of which must retain functional efficacy and meet regulatory safety criteria in application. It is argued herein that one of the major challenges currently faced in improving the robustness of routine stem-cell biomanufacturing is in utilizing continuous, meaningful assessments of molecular and cellular characteristics from process to application. This includes integrating process data with biological characteristic and functional assessment data to model the interplay between variables in the search for global optimization strategies. Coupling complete datasets with relevant computational methods will contribute significantly to model development and automation in achieving process robustness. This overarching approach is thus crucially important in realizing the potential of hiPSC biomanufacturing for transformation of regenerative medicine and the healthcare industry.James ColterKartikeya MurariJeff BiernaskieMichael Scott KallosNature PortfolioarticleMedicineRENnpj Regenerative Medicine, Vol 6, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R
spellingShingle	Medicine R James Colter Kartikeya Murari Jeff Biernaskie Michael Scott Kallos Induced pluripotency in the context of stem cell expansion bioprocess development, optimization, and manufacturing: a roadmap to the clinic
description	Abstract The translation of laboratory-scale bioprocess protocols and technologies to industrial scales and the application of human induced pluripotent stem cell (hiPSC) derivatives in clinical trials globally presents optimism for the future of stem-cell products to impact healthcare. However, while many promising therapeutic approaches are being tested in pre-clinical studies, hiPSC-derived products currently account for a small fraction of active clinical trials. The complexity and volatility of hiPSCs present several bioprocessing challenges, where the goal is to generate a sufficiently large, high-quality, homogeneous population for downstream differentiation—the derivatives of which must retain functional efficacy and meet regulatory safety criteria in application. It is argued herein that one of the major challenges currently faced in improving the robustness of routine stem-cell biomanufacturing is in utilizing continuous, meaningful assessments of molecular and cellular characteristics from process to application. This includes integrating process data with biological characteristic and functional assessment data to model the interplay between variables in the search for global optimization strategies. Coupling complete datasets with relevant computational methods will contribute significantly to model development and automation in achieving process robustness. This overarching approach is thus crucially important in realizing the potential of hiPSC biomanufacturing for transformation of regenerative medicine and the healthcare industry.
format	article
author	James Colter Kartikeya Murari Jeff Biernaskie Michael Scott Kallos
author_facet	James Colter Kartikeya Murari Jeff Biernaskie Michael Scott Kallos
author_sort	James Colter
title	Induced pluripotency in the context of stem cell expansion bioprocess development, optimization, and manufacturing: a roadmap to the clinic
title_short	Induced pluripotency in the context of stem cell expansion bioprocess development, optimization, and manufacturing: a roadmap to the clinic
title_full	Induced pluripotency in the context of stem cell expansion bioprocess development, optimization, and manufacturing: a roadmap to the clinic
title_fullStr	Induced pluripotency in the context of stem cell expansion bioprocess development, optimization, and manufacturing: a roadmap to the clinic
title_full_unstemmed	Induced pluripotency in the context of stem cell expansion bioprocess development, optimization, and manufacturing: a roadmap to the clinic
title_sort	induced pluripotency in the context of stem cell expansion bioprocess development, optimization, and manufacturing: a roadmap to the clinic
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/22bb2828f64c4c59b3fd201b40927c1f
work_keys_str_mv	AT jamescolter inducedpluripotencyinthecontextofstemcellexpansionbioprocessdevelopmentoptimizationandmanufacturingaroadmaptotheclinic AT kartikeyamurari inducedpluripotencyinthecontextofstemcellexpansionbioprocessdevelopmentoptimizationandmanufacturingaroadmaptotheclinic AT jeffbiernaskie inducedpluripotencyinthecontextofstemcellexpansionbioprocessdevelopmentoptimizationandmanufacturingaroadmaptotheclinic AT michaelscottkallos inducedpluripotencyinthecontextofstemcellexpansionbioprocessdevelopmentoptimizationandmanufacturingaroadmaptotheclinic
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Induced pluripotency in the context of stem cell expansion bioprocess development, optimization, and manufacturing: a roadmap to the clinic

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