Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility
David Pamies, Jason E. Ekert, Marie‐Gabrielle Zurich, Olivier Frey, Sophie Werner, Monica Piergiovanni, Benjamin Freedman, Adrian Kee Keong Teo, Hendrik Erfurth, Darwin R. Reyes, Peter Loskill, Pelin L. Candarlioglu, Laura Suter‐Dick, Shan Wang, Thomas Härtung, Sandra Coecke, Glyn Stacey, Beren Ataç Wagegg, Eva‐Maria Dehne, Francesca Pistollato, Marcel Leist
Abstract
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.