Policy & Regulation
CN Bio expands partnership with FDA to investigate lung-on-a-chip model for inhaled drug evaluation applications
5 May 2021 -

Microphysiological company CN Bio reported on Wednesday the receipt of approval to extend liver-on-a-chip platform research collaboration with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) by another three years.

The extension follows the success of the US FDA's initial four year agreement of advanced performance of the company's liver-on-a-chip MPS (microphysiological systems). The co-publication demonstrated the advanced performance of the company's liver-on-a-chip MPS. This is the first co-authored, peer-reviewed article between a microphysiological system provider and a regulator.

This research has now been broadened to include the exploration of its lung-on-a-chip using the company's PhysioMimix MPS platform to appraise the system's use for the evaluation of inhaled drug products and assessing additional applications for its liver model.

Under a similar process, the extended collaboration will involve studying lung microphysiological systems to obtain physiological relevant parameters for inhaled drug products. The performance of the lung microphysiological systems will be compared to traditional techniques.

Using MPS, the complex human-relevant 3D lung models can include accurate physiological micro-architecture; co-culture of lung-specific cell types and incorporation of innate immune cells. The researchers can create an organotypic air-liquid interface for evaluating the effects of environmental toxins, consumer products, and the safety and efficacy of new inhaled medicines, concluded the company.

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