02280nas a2200577   4500000000100000000000100001008004100002260001500043653002800058653001100086653003100097653001400128653002000142653003100162653001300193653001400206653003100220653001800251653001400269653002000283653002000303653002000323653001400343653001400357100001700371700001600388700002700404700001700431700001800448700002400466700002500490700002500515700002000540700002000560700001800580700002300598700002100621700001400642700001900656700001800675700001900693700002200712700002000734700002500754700001700779245015200796300001200948490000700960520072100967022001401688       2024                            d  c2024-05-1410aCell Culture Techniques10aHumans10amicrophysiological systems10aorganoids10aQuality Control10aReproducibility of Results10acriteria10ain vitro10amicrophysiological systems10aorgan on chip10aorganoids10aQuality Control10arecommendations10areproducibility10aspheroids10aStandards1 aDavid Pamies1 aJason Ekert1 aMarie-Gabrielle Zurich1 aOlivier Frey1 aSophie Werner1 aMonica Piergiovanni1 aBenjamin S. Freedman1 aAdrian Kee Keong Teo1 aHendrik Erfurth1 aDarwin R. Reyes1 aPeter Loskill1 aPelin Candarlioglu1 aLaura Suter-Dick1 aShan Wang1 aThomas Hartung1 aSandra Coecke1 aGlyn N. Stacey1 aBeren Atac Wagegg1 aEva-Maria Dehne1 aFrancesca Pistollato1 aMarcel Leist00aRecommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility  a604-6170 v193 aCell 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.  a2213-6711