CN Bio’s PhysioMimix technology receives FDA recognition

CN Bio, developer of single and multi organ-on-chip microphysiological systems (MPS) to improve the accuracy and efficiency of drug discovery, has published co-authored research with the US Food and Drug Administration (FDA)1.The first co-published, peer-reviewed research paper between a commercial MPS provider and a regulator, demonstrates that data derived using CN Bio’s proprietary PhysioMimix system is appropriate for use in drug safety and metabolism applications, evidencing its enhanced performance versus standard techniques.

Liver toxicity is a major safety concern during drug discovery and development, with the potential to terminate clinical trials and result in expensive program failures. It is estimated that companies could save 26% of drug discovery costs2through incorporation of MPS technologies, by generating human-relevant data that better predicts clinical outcomes. This co-publication with the FDA provides evidence of the advantage of MPS over standard techniques and clear criteria to ensure robust operation, both critical factors to enable the fast-track adoption of these technologies. Scientists at the FDA demonstrated CN Bio’s PhysioMimix MPS technology accurately models drug metabolism and detects compounds known to be toxic to humans. Markers of liver function were used to evidence the longevity, reliability, and reproducibility of the system.

CN Bio’s single and multi-organ MPS are designed to enable researchers to better replicate the micro-environments, cell-cell interactions and biological processes that occur in vivo, opening new possibilities for the pre-clinical evaluation of medicines. Confirmation by the FDA that the interaction between inflammation and liver toxicity can be observed in the system, highlights the complexity with which human biology can now be recapitulated. CN Bio says this publication fortifies the body of evidence demonstrating how PhysioMimix technology can rapidly generate human-relevant, robust data that is clinically translatable and predictive, facilitating more insightful, accurate and cost-effective drug development, for improved clinical success.

 

1Characterizing the Reproducibility in Using a Liver Microphysiological System for Assaying Drug Toxicity, Metabolism and Accumulation’, Clinical and Translational Science https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.12969

2‘Impact of organ-on-a-chip technology on pharmaceutical R&D costs’ https://www.sciencedirect.com/science/article/pii/S135964461930042X

Related Articles

Join FREE today and become a member
of Drug Discovery World

Membership includes:

  • Full access to the website including free and gated premium content in news, articles, business, regulatory, cancer research, intelligence and more.
  • Unlimited App access: current and archived digital issues of DDW magazine with search functionality, special in App only content and links to the latest industry news and information.
  • Weekly e-newsletter, a round-up of the most interesting and pertinent industry news and developments.
  • Whitepapers, eBooks and information from trusted third parties.
Join For Free