TY - JOUR KW - Cell Culture Techniques KW - Humans KW - microphysiological systems KW - organoids KW - Quality Control KW - Reproducibility of Results KW - criteria KW - in vitro KW - microphysiological systems KW - organ on chip KW - organoids KW - Quality Control KW - recommendations KW - reproducibility KW - spheroids KW - Standards AU - David Pamies AU - Jason Ekert AU - Marie-Gabrielle Zurich AU - Olivier Frey AU - Sophie Werner AU - Monica Piergiovanni AU - Benjamin S. Freedman AU - Adrian Kee Keong Teo AU - Hendrik Erfurth AU - Darwin R. Reyes AU - Peter Loskill AU - Pelin Candarlioglu AU - Laura Suter-Dick AU - Shan Wang AU - Thomas Hartung AU - Sandra Coecke AU - Glyn N. Stacey AU - Beren Atac Wagegg AU - Eva-Maria Dehne AU - Francesca Pistollato AU - Marcel Leist AB - 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. BT - Stem Cell Reports DA - 2024-05-14 DO - 10.1016/j.stemcr.2024.03.009 IS - 5 LA - eng N2 - 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. PY - 2024 SP - 604 EP - 617 T2 - Stem Cell Reports TI - Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility VL - 19 SN - 2213-6711 ER -