The value of organs-on-chip for regulatory safety assessment

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Minne B. Heringa
Margriet V. D. Z. Park
Anne S. Kienhuis
Rob J. Vandebriel


Organs-on-chip (OC) have gained high interest as animal-free toxicity testing method due to their higher resemblance to human tissues and longer culture viability than conventional in vitro methods. The current paper discusses where and how OCs may take a role in the transition to a more predictive, animal-free safety assessment for regulatory purposes. From a preliminary analysis of a repeated dose toxicity database, ten organs of priority for OC development for regulatory use have been identified. For a number of these organs (lung, skin, liver, kidney, heart, and intestine), OCs are already at rather advanced stages of development, such that involvement of regulators becomes of value in the optimisation towards fitness-for-purpose of these methods. For organs such as testis, spleen, brain, and stomach, OCs are much more premature, if existing at all. Therefore, developmental work on OCs for these latter organs is expected to stay in the academic arena for the coming time. A number of technical recommendations and some challenges in reaching final implementation are discussed. We recommend the development of OCs to go together with the development of Adverse Outcome Pathways and combining them with other methods into integrated testing strategies. Overall, opportunities exist, but there is still much that needs to be done. In our view, regular interactions in multi-stakeholder workshops on application of animal-free innovations such as OCs will be beneficial.

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How to Cite
Heringa, M., Park, M., Kienhuis, A. and Vandebriel, R. (2019) “The value of organs-on-chip for regulatory safety assessment”, ALTEX - Alternatives to animal experimentation. doi: 10.14573/altex.1910111.