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

Affiliations

• ¹ Department of Biomedical Science, University of Lausanne, Lausanne, Switzerland; Swiss Centre for Applied Human Toxicology (SCAHT), Basel, Switzerland. Electronic address: [email protected].
• ² Jason E Ekert: UCB Pharma, Cambridge, MA, USA.
• ³ Department of Biomedical Science, University of Lausanne, Lausanne, Switzerland; Swiss Centre for Applied Human Toxicology (SCAHT), Basel, Switzerland.
• ⁴ InSphero AG, Schlieren, Switzerland.
• ⁵ 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.
• ⁶ European Commission, Joint Research Centre (JRC), Ispra, Italy.
• ⁷ 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.
• ⁸ 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.
• ⁹ TissUse GmbH, Berlin, Germany.
• ¹⁰ National Institute of Standards and Technology, Gaithersburg, MD, USA.
• ¹¹ 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.
• ¹² 3D and 3Rs Ltd., 115c Milton Road, Cambridge CB4 1XE, UK.
• ¹³ Swiss Centre for Applied Human Toxicology (SCAHT), Basel, Switzerland; University of Applied Sciences and Arts Northwestern Switzerland, School of Life Sciences, Muttenz, Switzerland.
• ¹⁴ Department of Biomedical Science, University of Lausanne, Lausanne, Switzerland.
• ¹⁵ 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.
• ¹⁶ 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.
• ¹⁷ Humane Society International, Rue Belliard 40, 1040 Bruxelles, Belgium.
• ¹⁸ CAAT Europe, University of Konstanz, Konstanz, Germany; In vitro Toxicology and Biomedicine, Department inaugurated by the Doerenkamp-Zbinden foundation, University of Konstanz, Konstanz, Germany.