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Characterizing the reproducibility in using a liver microphysiological system for assaying drug toxicity, metabolism and accumulation
Filed under: ADME, DILI, Drug metabolism, Immune-medicated toxicity, and Safety toxicology
Rubiano et al., 2020
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. The publication substantiates the Company’s position as a leader in the field with reliable and robust cutting-edge technology, ready for widespread adoption across the pharmaceutical industry.
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 costs through 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.