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

Type
01A - Journal article
Editors
Editor (Corporation)
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Parent work
Stem Cell Reports
Special issue
DOI of the original publication
Link
Series
Series number
Volume
19
Issue / Number
5
Pages / Duration
604-617
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Publisher / Publishing institution
Cell Press
Place of publication / Event location
Edition
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Abstract
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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ISBN
ISSN
2213-6711
Language
English
Created during FHNW affiliation
Yes
Strategic action fields FHNW
Publication status
Published
Review
Peer review of the complete publication
Open access category
Gold
License
'https://creativecommons.org/licenses/by/4.0/'
Citation
Pamies, D., Ekert, J., Zurich, M.-G., Frey, O., Werner, S., Piergiovanni, M., Freedman, B. S., Keong Teo, A. K., Erfurth, H., Reyes, D. R., Loskill, P., Candarlioglu, P., Suter-Dick, L., Wang, S., Hartung, T., Coecke, S., Stacey, G. N., Wagegg, B. A., Dehne, E.-M., et al. (2024). Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility. Stem Cell Reports, 19(5), 604–617. https://doi.org/10.1016/j.stemcr.2024.03.009