@article{3446, keywords = {Cell Culture Techniques, Humans, microphysiological systems, organoids, Quality Control, Reproducibility of Results, criteria, in vitro, microphysiological systems, organ on chip, organoids, Quality Control, recommendations, reproducibility, spheroids, Standards}, author = {David Pamies and Jason Ekert and Marie-Gabrielle Zurich and Olivier Frey and Sophie Werner and Monica Piergiovanni and Benjamin S. Freedman and Adrian Kee Keong Teo and Hendrik Erfurth and Darwin R. Reyes and Peter Loskill and Pelin Candarlioglu and Laura Suter-Dick and Shan Wang and Thomas Hartung and Sandra Coecke and Glyn N. Stacey and Beren Atac Wagegg and Eva-Maria Dehne and Francesca Pistollato and Marcel Leist}, title = {Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility}, 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.}, year = {2024}, journal = {Stem Cell Reports}, volume = {19}, pages = {604-617}, month = {2024-05-14}, issn = {2213-6711}, doi = {10.1016/j.stemcr.2024.03.009}, language = {eng}, }