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

Classical single-cell and monolayer models have been increasingly replaced by more complex 3D models, combined with bioengineering technologies to develop cultures that better represent the tissue microenvironment. These new cell systems are called “microphysiological systems (MPS)”, that are already driving advances in both basic research and biomedical applications, and have been recently applied to deliver important biomedical information. However, the complexity of MPS makes their standardization challenging. Many early MPS devices are designed within academic laboratories, which makes reproducibility more difficult, impacting reliability and acceptance of scientific results. Therefore, it is important to agree within the user community on good practices and quality assurance of MPS that is adapted to their intended use (fit-for-purpose criteria). Here, we present guidance for establishing such criteria, and give examples from publications that describe MPS use. The purpose of the present document is to provide alerts for quality concerns and suggest a broad range of potential quality control measures, supported by several examples. Ultimately, directly applicable advice is provided to MPS developers on important quality considerations and on how to ensure a reproducible performance for given purposes.

PAMIES David;  EKERT Jason;  ZURICH Marie-Gabrielle;  FREY Olivier;  WERNER Sophie;  PIERGIOVANNI Monica;  FREEDMAN Benjamin S.;  KEE KEONG Adrian;  ERFURTH Hendrik;  REYES Darwin;  LOSKILL Peter;  CANDARLIOGLU Pelin;  SUTER-DICK Laura;  WANG Shan;  HARTUNG T.;  COECKE Sandra;  STACEY Glyn;  ATAC WAGEGG Beren;  DEHNE Eva Maria;  PISTOLLATO Francesca;  LEIST Marcel; 

2024-05-29

CELL PRESS

JRC135648

2213-6711 (online),   

https://www.sciencedirect.com/science/article/pii/S2213671124000845,    https://publications.jrc.ec.europa.eu/repository/handle/JRC135648,   

10.1016/j.stemcr.2024.03.009 (online),