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EBiSC best practice: How to ensure optimal generation, qualification, and distribution of iPSC lines

Rachel Steeg, Sabine Mueller, Nancy Mah, Bjørn Holst, Alfredo Cabrera‐Socorro, Glyn Stacey, Paul A. De Sousa, A. Courtney, Heiko Zimmermann

2021Stem Cell Reports37 citationsDOIOpen Access PDF

Abstract

•Ethics for iPSCs must be explicit, GDPR compliant, and allow future research•iPSC use restrictions are linked to consent, reprogramming, and gene editing•Quality control must be implemented from primary tissue handling onward•Robust data management is essential to ensure privacy and enable data sharing Disease-relevant human induced pluripotent stem cells (iPSCs) are generated worldwide for research purposes; however, without robust and practical ethical, legal, and quality standards, there is a high risk that their true potential will not be realized. Best practices for tissue procurement, iPSC reprogramming, day-to-day cultivation, quality control, and data management aligned with an ethical and legal framework must be included into daily operations to ensure their promise is maximized. Here we discuss key learning experiences from 7 years of operating the European Bank for induced Pluripotent Stem Cells (EBiSC) and recommend how to incorporate solutions into a daily management framework. Disease-relevant human induced pluripotent stem cells (iPSCs) are generated worldwide for research purposes; however, without robust and practical ethical, legal, and quality standards, there is a high risk that their true potential will not be realized. Best practices for tissue procurement, iPSC reprogramming, day-to-day cultivation, quality control, and data management aligned with an ethical and legal framework must be included into daily operations to ensure their promise is maximized. Here we discuss key learning experiences from 7 years of operating the European Bank for induced Pluripotent Stem Cells (EBiSC) and recommend how to incorporate solutions into a daily management framework.

Topics & Concepts

ReprogrammingInduced pluripotent stem cellProcurementBiologyRisk analysis (engineering)Quality (philosophy)Best practiceRisk managementControl (management)BusinessBiotechnologyComputer scienceMarketingArtificial intelligenceEmbryonic stem cellManagementEconomicsFinanceGenePhilosophyBiochemistryCellGeneticsEpistemologyPluripotent Stem Cells ResearchCRISPR and Genetic EngineeringBiomedical Ethics and Regulation
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