Recommendations on fit-for-purpose criteria to establish a quality management for microphysiological systems (MPS) and for monitoring of their reproducibility

Published

May 14, 2024

Author(s)

David Pamies, Jason Ekert, Marie-Gabrielle Zurich, Olivier Frey, Sophie Werner, MONICA PIERGIOVANNI, Benjamin Freedman, Adrian Keong, Darwin Reyes-Hernandez, Hendrik Erfurth, Peter Loskill, Pelin Candarlioglu, Shan Wang, Thomas Hartung, Sandra Coecke, Glyn Stacey, Marcel Leist

Abstract

Cell culture technology has seen great innovations and progress in the 21st centuryClassical single-cell and monolayer models have been replaced by more complex 3D models (e.g., reaggregates, spheroids, organoids) to improve the predictivity of in vitro data for tissues and whole organisms. New culture formats have been combined with bioengineering technologies (e.g., microfabrication, microfluidics, cell printing, extracellular matrix constructs) to develop cultures that better represent the tissue microenvironment. These new cell systems are here collectively called "microphysiological systems (MPS)". Such MPS are perceived as tools that will drive advances in both basic research and biomedical applications. They have already been applied to deliver important biomedical information, e.g., during the covid-19 pandemic. The complexity of MPS makes their standardization challenging. A low reproducibility would negatively affect the reliability of the scientific data obtained. 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 a guidance for establishing such criteria, and we give examples from many MPS publications that describe their use. This approach complements earlier extensive work on Good Cell and Tissue Culture Practice (Eskes et al. 2017; Pamies et al. 2017a; Pamies et al. 2020a; Pamies et al. 2022; Pistollato et al. 2022a; Stacey et al. 2016). The purpose of the present document is to provide alerts for quality concerns and suggest a broad range of potential quality control measures. General considerations are illustrated by many examples. The main theme is to provide directly applicable advice to MPS developers on important quality considerations and on how to ensure a reproducible performance for given purposes.

Citation

Altex

Volume

19

Pub Type

Journals

Download Paper

https://doi.org/10.1016/j.stemcr.2024.03.009

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Keywords

Microphysiological systems, MPS, organ-on-a-chip, lab-on-a-chip, fit-for-purpose, tissue-on-a-chip, standards, guidelines

Citation

Pamies, D. , Ekert, J. , Zurich, M. , Frey, O. , Werner, S. , PIERGIOVANNI, M. , Freedman, B. , Keong, A. , Reyes-Hernandez, D. , Erfurth, H. , Loskill, P. , Candarlioglu, P. , Wang, S. , Hartung, T. , Coecke, S. , Stacey, G. and Leist, M. (2024), Recommendations on fit-for-purpose criteria to establish a quality management for microphysiological systems (MPS) and for monitoring of their reproducibility, Altex, [online], https://doi.org/10.1016/j.stemcr.2024.03.009, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=956588 (Accessed November 20, 2024)