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Cell culture technology has evolved, moving from single-cell and monolayer methods to 3D models like reaggregates, spheroids, and organoids, improved with bioengineering like microfabrication and bioprinting. These advancements, termed microphysiological systems (MPSs), closely replicate tissue environments and human physiology, enhancing research and biomedical uses. However, MPS complexity introduces standardization challenges, impacting reproducibility and trust. We offer guidelines for quality management and control criteria specific to MPSs, facilitating reliable outcomes without stifling innovation. Our fit-for-purpose recommendations provide actionable advice for achieving consistent MPS performance., Competing Interests: Declaration of interests A.K.K.T. is a co-founder and shareholder of BetaLife Pte Ltd but is not employed by BetaLife Pte Ltd. B.S.F. is an inventor on patents and/or patent applications related to human kidney organoid differentiation and modeling of disease in this system (these include “Three-dimensional differentiation of epiblast spheroids into kidney tubular organoids modeling human microphysiology, toxicology, and morphogenesis” [Japan, US, and Australia], licensed to STEMCELL Technologies; “High-throughput automation of organoids for identifying therapeutic strategies” [PTC patent application pending]; and “Systems and methods for characterizing pathophysiology” [PTC patent application pending]), and holds ownership interest in Plurexa LLC. T.H. and D.P. are named inventors on a patent by Johns Hopkins University on the production of mini-brains (also called BrainSpheres), which is licensed to AxoSim, New Orleans, LA, USA. T.H., D.P., and L.S.-D. consult AxoSim and T.H. is a shareholder. T.H. consults AstraZeneca, American Type Culture Collection, InSphero, and Apellis Pharmaceuticals on microphysiological systems., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

The generation of donor-derived induced pluripotent stem cells (iPSCs) for allogeneic transplantation is a major challenge in regenerative medicine. Yoshida et al. now report on the establishment of an HLA-homozygous haplobank of iPSCs that covers approximately 40% of the Japanese population and describe quality and safety considerations for manufacturing., Competing Interests: Declaration of interests G.N.S. is an employee and shareholder of SSCBio Ltd, an independent consultancy., (Copyright © 2023. Published by Elsevier Inc.)

It is well established that human pluripotent stem cells (hPSCs) can acquire genetic and epigenetic changes during culture in vitro. Given the increasing use of hPSCs in research and therapy and the vast expansion in the number of hPSC lines available for researchers, the International Society for Stem Cell Research has recognized the need to reassess quality control standards for ensuring the genetic integrity of hPSCs. Here, we summarize current knowledge of the nature of recurrent genetic and epigenetic variants in hPSC culture, the methods for their detection, and what is known concerning their effects on cell behavior in vitro or in vivo. We argue that the potential consequences of low-level contamination of cell therapy products with cells bearing oncogenic variants are essentially unknown at present. We highlight the key challenges facing the field with particular reference to safety assessment of hPSC-derived cellular therapeutics., Competing Interests: Declaration of interests P.W.A. receives royalties from the Wistar Institute for sales of antibodies., (Copyright © 2022 Elsevier Inc. All rights reserved.)

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., (Copyright © 2021 Fraunhofer Institut fû¥r Biomedizinische Technik. Published by Elsevier Inc. All rights reserved.)

The past decade has witnessed an extremely rapid increase in the number of newly established stem cell lines. However, due to the lack of a standardized format, data exchange among stem cell line resources has been challenging, and no system can search all stem cell lines across resources worldwide. To solve this problem, we have developed the Integrated Collection of Stem Cell Bank data (ICSCB) (http://icscb.stemcellinformatics.org/), the largest database search portal for stem cell line information, based on the standardized data items and terms of the MIACARM framework. Currently, ICSCB can retrieve >16,000 cell lines from four major data resources in Europe, Japan, and the United States. ICSCB is automatically updated to provide the latest cell line information, and its integrative search helps users collect cell line information for over 1,000 diseases, including many rare diseases worldwide, which has been a formidable task, thereby distinguishing itself from other database search portals., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Data sharing is an essential element of research; however, recent scientific and social developments have challenged conventional methods for protecting privacy. Here we provide guidance for determining data sharing thresholds for human pluripotent stem cell research aimed at a wide range of stakeholders, including research consortia, biorepositories, policy-makers, and funders., (Copyright © 2014 Elsevier Inc. All rights reserved.)

The generation of human embryonic stem cell banking networks has ensured that well-characterized and quality controlled stem cell lines are broadly accessible to researchers worldwide. Here, we provide recommendations for engaging these established networks in efforts to build similar resources for the distribution and collection of induced pluripotent stem cells., (Copyright © 2013 Elsevier Inc. All rights reserved.)