The FDA has extended a collaboration with the UK firm CN Bio to investigate a “lung-on-a-chip” model to investigate inhaled drugs.
In a statement the firm said the move follows the success of a pilot project to assess the performance of the technology.
Based in Cambridge, UK, CN Bio has been working with the FDA for four years, which has resulted in the co-publication of an article discussing the performance of the technology.
Published in the journal Clinical and Translational Science, this was the first co-authored peer-reviewed article between a company working in microphysiological systems and a regulator.
The agreement has been extended by a further three years and the scope of the research has been broadened.
The extended research agreement will include exploration of CN Bio’s lung-on-a-chip using the company’s PhysioMimix platform.
This will appraise the system for evaluation of inhaled drug products and assessing additional applications for CN Bio’s liver mode.
Development and regulatory assess of novel and generic pulmonary therapeutics can be aided by tools that provide reliable measurements of certain parameters.
The system aims to test performance against measures such as drug absorption, metabolism and permeability in the lungs.
It can create 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.
Researchers can create an 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.”
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