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

Stem Cell Reports. 2024 May 14;19(5):604-617. doi: 10.1016/j.stemcr.2024.03.009. Epub 2024 Apr 25.


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.

Keywords: criteria; in vitro; microphysiological systems; organ on chip; organoids; quality control; recommendations; reproducibility; spheroids; standards.

Publication types

  • Review

MeSH terms

  • Cell Culture Techniques* / methods
  • Humans
  • Microphysiological Systems
  • Organoids / cytology
  • Quality Control
  • Reproducibility of Results