Development of allogeneic iPS cell-based therapy: from bench to bedside

David H. McKenna; Rita C.R. Perlingeiro

doi:10.15252/emmm.202115315

Development of allogeneic iPS cell-based therapy: from bench to bedside

Research output: Contribution to journal › Comment/debate › peer-review

Abstract

This commentary provides a brief overview of the steps necessary for the generation of an induced pluripotent stem (iPS) cell-derived clinical grade product. This process requires extensive, proper documentation as well as a thoughtful and systematic optimization of the manufacturing methods to ensure maintenance of the key biological features of the product, compliance with current good manufacturing practices (cGMP), and most importantly patient safety. The scale-up and optimization also ideally include the identification of efficient and cost-effective purification/isolation and expansion of the target cell population.

Original language	English (US)
Article number	e15315
Journal	EMBO Molecular Medicine
Volume	15
Issue number	2
DOIs	https://doi.org/10.15252/emmm.202115315
State	Published - Feb 8 2023

Bibliographical note

Funding Information:
DHM and RCRP acknowledge current and previous support from the NIH‐NIAMS (R01 AR071439), Department of Defense (W81XWH‐17‐1‐0659), and Duchene UK (#1147094). We thank Sophia Kyba for suggestions with graphical design.

Funding Information:
DHM and RCRP acknowledge current and previous support from the NIH-NIAMS (R01 AR071439), Department of Defense (W81XWH-17-1-0659), and Duchene UK (#1147094). We thank Sophia Kyba for suggestions with graphical design.

Publisher Copyright:
© 2022 The Authors. Published under the terms of the CC BY 4.0 license.

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10.15252/emmm.202115315License: CC BY

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abstract = "This commentary provides a brief overview of the steps necessary for the generation of an induced pluripotent stem (iPS) cell-derived clinical grade product. This process requires extensive, proper documentation as well as a thoughtful and systematic optimization of the manufacturing methods to ensure maintenance of the key biological features of the product, compliance with current good manufacturing practices (cGMP), and most importantly patient safety. The scale-up and optimization also ideally include the identification of efficient and cost-effective purification/isolation and expansion of the target cell population.",

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AB - This commentary provides a brief overview of the steps necessary for the generation of an induced pluripotent stem (iPS) cell-derived clinical grade product. This process requires extensive, proper documentation as well as a thoughtful and systematic optimization of the manufacturing methods to ensure maintenance of the key biological features of the product, compliance with current good manufacturing practices (cGMP), and most importantly patient safety. The scale-up and optimization also ideally include the identification of efficient and cost-effective purification/isolation and expansion of the target cell population.

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Development of allogeneic iPS cell-based therapy: from bench to bedside

Abstract

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