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

The need for improved drug response prediction, more effective modelling of disease and diverse microenvironments, has led to advancements in cell culture technology. Researchers are moving beyond traditional 2D models to embrace sophisticated 3D microphysiological systems (MPSs) like organoids and organ-on-chip models. These cutting-edge systems offer a closer mimicry of human tissues and physiology, a branch of biology that studies the functions and mechanisms of living organisms, paving the way for significant breakthroughs in research and biomedical applications.
However, the increased complexity of MPSs introduces new challenges in standardization and reproducibility. Standardization is the process of establishing uniform procedures, to ensure consistency and reliability and to reduce variability. Reproducibility is the ability to obtain the same results when a procedure is repeated under the same conditions, it demonstrates that the results are not due to random chance. Without standardized and reproducible methods the overall trust in these novel technologies is not ensured. 

In our recent publication, we address these challenges by introducing new guidelines for quality management and control specifically tailored to MPSs. We want to answer the question: “Which quality standards should MPS meet”? 

Our recommendations aim to standardize quality management and to enhance reproducibility. The goal is to support researchers and developers in achieving reliable, reproducible outcomes while fostering continued advancements in microphysiological systems. For detailed recommendations explore the guidelines and learn how to implement them in your work.

D. Pamies, J. Ekert, M.-G. Zurich, O. Frey, S. Werner, M. Piergiovanni, B. S. Freedman, A. Kee Keong Teo, H. Erfurth, D. R. Reyes, P. Loskill, P. Candarlioglu, L. Suter-Dick, S. Wang, T. Hartung, S. Coecke, G. N. Stacey, B. Atac Wagegg, E.-M. Dehne, F. Pistollato, M. Leist
Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility
Stem Cell Rep.2024, 19, 604-617, https://doi.org/10.1016/j.stemcr.2024.03.009