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Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility
Summary
Researchers developed quality management guidelines for microphysiological systems — miniature lab models that mimic human tissue and organ behavior — to improve the consistency and reliability of results across different laboratories. Standardizing these systems is critical for replacing animal testing and generating trustworthy safety data for chemicals including nanoplastics.
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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