Early Qualification of Microphysiological Systems for Regulatory Science
Author Information
Author(s): Weener Huub J., Middelkamp Heleen H. T., Van der Meer Andries D.
Primary Institution: University of Twente
Hypothesis
To what extent can aspects of qualification be performed during early development stages of microphysiological systems and organs-on-chips?
Conclusion
Incorporating qualification early in the development of microphysiological systems can enhance their reliability and acceptance in regulatory contexts.
Supporting Evidence
- Microphysiological systems can replicate complex human biological processes in vitro.
- Qualification is essential for the adoption of these models in regulatory science.
- Early qualification efforts can enhance the reliability and ethical acceptance of new methodologies.
Takeaway
This study shows that scientists can make sure their lab models are ready for real-world use by thinking about how they will be used right from the start.
Methodology
The study involved a case study of a blood-perfused Vessel-on-Chip model to explore qualification aspects during early development.
Potential Biases
Variability in biological materials and donor characteristics may introduce bias.
Limitations
The model is limited to endothelial cells and cannot account for tissue-resident immune cells or long-term effects.
Digital Object Identifier (DOI)
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