The FDA further expands collaboration with CN Bio to evaluate the PhysioMimix Multi-organ microphysiological system

CN Bio, a leading Organ-on-a-chip Company (OOC) that designs and manufactures single-and multi-organ microphysiological systems (MPS), today announced that the U.S. Food and Drug Administration (FDA) and CN Bio have expanded their collaboration for the second time, with new research aiming to evaluate multi-organ MPS and their applications using the PhysioMimix™ Multi-organ System. Building on the success of prior studies, the system will initially be investigated for improving the preclinical estimation of human drug bioavailability compared to standard animal models.

For orally administered drugs, a critical parameter that needs to be understood by drug developers and regulatory agencies is bioavailability. Bioavailability is defined as the fraction of drug reaching the bloodstream. Accurately predicting the bioavailability of orally administered medicines in humans during preclinical development is crucial as it forms the basis for setting safe and efficacious doses in the clinic. Animal models currently dominate when estimating bioavailability, but evidence has shown these models are poor predictors in part due to inherent physiological and metabolic differences. Paving the way for approaches such as MPS, the recently passed FDA Modernization Act 2.0 has removed the mandatory requirement for animal testing for toxicity where enhanced performance is proven using in vitro alternatives1.

Read more