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

Stem Cell Reports
Pamies David, Ekert Jason, Zurich Marie-Gabrielle, Frey Olivier, Werner Sophie, Piergiovanni Monica, Freedman Benjamin S., Keong Teo Adrian Kee, Erfurth Hendrik, Reyes Darwin R., Loskill Peter, Candarlioglu Pelin, Suter-Dick Laura, Wang Shan, Hartung Thomas, Coecke Sandra, Stacey Glyn, Atac Wagegg Beren, Dehne Eva-Maria, Pistollato Francesca, Leist Marcel
DOI: 10.1016/j.stemcr.2024.03.009
PMID: 38670111
Keyword: Criteria · In vitro · Microphysiological systems · Organ on chip · Organoids · Quality control · Recommendations · Reproducibility · Spheroids · Standards


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.