The FDA Expands Collaboration With CN Bio to Investigate Lung-on-a-Chip Model for Inhaled Drug Evaluation Applications

CN Bio recently announced the US FDA has extended its research collaboration for an additional 3 years. The scope of the research carried out with the FDA’s Center for Drug Evaluation and Research (CDER) has now been broadened to include the exploration of CN Bio’s lung-on-a-chip using the PhysioMimix MPS platform, to appraise the system’s use for the evaluation of inhaled drug products and assessing additional applications for CN Bio’s liver model.

The extension follows the success of CN Bio and the FDA’s initial 4-year agreement, culminating in a co-publication that demonstrated the advanced performance of the company’s liver-on-a-chip MPS; the first co-authored, peer-reviewed article between a microphysiological system provider and a regulator. With a plan to follow 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.

Successful development and regulatory assessment of novel and generic pulmonary therapeutics can be enhanced by drug development tools that provide reliable measurements of key parameters, such as drug absorption, metabolism, and permeability in the lungs. Using MPS, 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. In doing so, researchers can create an organotypic air-liquid interface, with more utility than current approaches, for evaluating the effects of environmental toxins, consumer products, and the safety and efficacy of new inhaled medicines.

Dr. David Hughes, CEO, CN Bio, said “This expanded collaborative project with the world’s leading regulator, the FDA, sends a reinforcing message to the pharmaceutical sector supporting the use of organ-on-a-chip microphysiological systems. The data from our previous study fortifies the growing body of evidence demonstrating the utility of CN Bio’s platforms and encouraging the adoption of MPS into drug discovery and development workflows. Following the co-publication, we have seen a significant increase in customer interest surrounding our liver MPS, and expect similarly exciting outcomes for this upcoming lung project.”

CN Bio is a leading cell culture company that has developed single- and multi-organ microphysiological systems (MPS) that improve the accuracy and efficiency of drug discovery. With more than a decade of research and development experience in multi-organ microphysiology, the company aims to transform the way human-relevant pre-clinical data is generated through the development of the most complete model of the human “Body-on-a-Chip” in the laboratory.

CN Bio’s organ-on-chip systems, which include the PhysioMimix™ lab-benchtop instrument, enable researchers to model human biology in the lab through rapid and predictive 3D human tissue-based studies that harness microfluidic technology. The technology bridges the gap between traditional cell culture and human studies, advancing towards the simulation of human biological conditions to support the accelerated development of new therapeutics in application areas including oncology, infectious diseases, metabolism and inflammation.

CN Bio supports researchers that require data-rich in vitro studies for the analysis of novel compounds, and assessment of toxicity and safety, in addition to supporting investigation into a broad range of biological processes across different organ cell-types, in application areas including ADME and toxicology, disease modelling, drug discovery, drug metabolism and pharmacokinetics, and drug repurposing.

CN Bio’s technology is licensed from Massachusetts Institute of Technology (MIT) and Vanderbilt University, and has been successfully adopted by numerous pharma and academic partners. CN Bio’s headquarters and laboratories are based in Cambridge, UK, with an international network of distributors. For more information about CN Bio’s products and services, visit: https://cn-bio.com/physiomimixooc/.