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

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.
Competing Interests: Declaration of interests A.K.K.T. is a co-founder and shareholder of BetaLife Pte Ltd but is not employed by BetaLife Pte Ltd. B.S.F. is an inventor on patents and/or patent applications related to human kidney organoid differentiation and modeling of disease in this system (these include “Three-dimensional differentiation of epiblast spheroids into kidney tubular organoids modeling human microphysiology, toxicology, and morphogenesis” [Japan, US, and Australia], licensed to STEMCELL Technologies; “High-throughput automation of organoids for identifying therapeutic strategies” [PTC patent application pending]; and “Systems and methods for characterizing pathophysiology” [PTC patent application pending]), and holds ownership interest in Plurexa LLC. T.H. and D.P. are named inventors on a patent by Johns Hopkins University on the production of mini-brains (also called BrainSpheres), which is licensed to AxoSim, New Orleans, LA, USA. T.H., D.P., and L.S.-D. consult AxoSim and T.H. is a shareholder. T.H. consults AstraZeneca, American Type Culture Collection, InSphero, and Apellis Pharmaceuticals on microphysiological systems.
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