Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility
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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.
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PAMIES, David, Jason EKERT, Marie-Gabrielle ZURICH, Olivier FREY, Sophie WERNER, Monica PIERGIOVANNI, Benjamin S. FREEDMAN, Adrian Kee KEONG TEO, Thomas HARTUNG, Marcel LEIST, 2024. Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility. In: Stem Cell Reports. Elsevier. 2024, 19(5), S. 604-617. eISSN 2213-6711. Verfügbar unter: doi: 10.1016/j.stemcr.2024.03.009BibTex
@article{Pamies2024-05Recom-69980, year={2024}, doi={10.1016/j.stemcr.2024.03.009}, title={Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility}, number={5}, volume={19}, journal={Stem Cell Reports}, pages={604--617}, author={Pamies, David and Ekert, Jason and Zurich, Marie-Gabrielle and Frey, Olivier and Werner, Sophie and Piergiovanni, Monica and Freedman, Benjamin S. and Keong Teo, Adrian Kee and Hartung, Thomas and Leist, Marcel} }
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