Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility.

Autor:	Pamies D; Department of Biomedical Science, University of Lausanne, Lausanne, Switzerland; Swiss Centre for Applied Human Toxicology (SCAHT), Basel, Switzerland. Electronic address: david.pamies@unil.ch., Ekert J; Jason E Ekert: UCB Pharma, Cambridge, MA, USA., Zurich MG; Department of Biomedical Science, University of Lausanne, Lausanne, Switzerland; Swiss Centre for Applied Human Toxicology (SCAHT), Basel, Switzerland., Frey O; InSphero AG, Schlieren, Switzerland., Werner S; Swiss Centre for Applied Human Toxicology (SCAHT), Basel, Switzerland; University of Applied Sciences and Arts Northwestern Switzerland, School of Life Sciences, Muttenz, Switzerland; Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland., Piergiovanni M; European Commission, Joint Research Centre (JRC), Ispra, Italy., Freedman BS; Division of Nephrology, Kidney Research Institute, and Institute for Stem Cell and Regenerative Medicine, Department of Medicine, University of Washington, Seattle, WA 98109, USA; Plurexa LLC, Seattle, WA 98109, USA., Keong Teo AK; Stem Cells and Diabetes Laboratory, Institute of Molecular and Cell Biology (IMCB), Agency for Science, Technology and Research (A(∗)STAR), Proteos, Singapore, Singapore; Department of Biochemistry, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore; Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore; Precision Medicine Translational Research Programme (TRP), Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore., Erfurth H; TissUse GmbH, Berlin, Germany., Reyes DR; National Institute of Standards and Technology, Gaithersburg, MD, USA., Loskill P; NMI Natural and Medical Sciences Institute at the University of Tübingen, Reutlingen, Germany; Department for Microphysiological Systems, Institute of Biomedical Engineering, Faculty of Medicine, Eberhard Karls University Tübingen, Tübingen, Germany; 3R Center for In Vitro Models and Alternatives to Animal Testing, Eberhard Karls University Tübingen, Tübingen, Germany., Candarlioglu P; 3D and 3Rs Ltd., 115c Milton Road, Cambridge CB4 1XE, UK., Suter-Dick L; Swiss Centre for Applied Human Toxicology (SCAHT), Basel, Switzerland; University of Applied Sciences and Arts Northwestern Switzerland, School of Life Sciences, Muttenz, Switzerland., Wang S; Department of Biomedical Science, University of Lausanne, Lausanne, Switzerland., Hartung T; Doerenkamp-Zbinden Professor and Chair for Evidence-based Toxicology, Johns Hopkins Bloomberg School of Public Health and Whiting School of Engineering, Baltimore, MD, USA; CAAT Europe, University of Konstanz, Konstanz, Germany., Coecke S; European Commission, Joint Research Centre (JRC), Ispra, Italy., Stacey GN; International Stem Cell Banking Initiative, 2 High Street, Barley, Herts SG88HZ, UK; National Stem Cell Resource Centre, Institute of Zoology, Chinese Academy of Sciences, Beijing 100190, China; Institute for Stem Cell and Regenerative Merdicine, Chinese Academy of Sciences, Beijing 100101, China., Wagegg BA; TissUse GmbH, Berlin, Germany., Dehne EM; TissUse GmbH, Berlin, Germany., Pistollato F; Humane Society International, Rue Belliard 40, 1040 Bruxelles, Belgium., Leist M; CAAT Europe, University of Konstanz, Konstanz, Germany; In vitro Toxicology and Biomedicine, Department inaugurated by the Doerenkamp-Zbinden foundation, University of Konstanz, Konstanz, Germany.
Jazyk:	angličtina
Zdroj:	Stem cell reports [Stem Cell Reports] 2024 May 14; Vol. 19 (5), pp. 604-617. Date of Electronic Publication: 2024 Apr 25.
DOI:	10.1016/j.stemcr.2024.03.009
Abstrakt:	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.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu