CN Bio logoCN Bio logoCN Bio logoCN Bio logo
  • Products
    • Explore our solutions


      PhysioMimix™ products enable you to recreate complex human biology and accurately predict human drug responses

      PhysioMimix OOC

      PhysioMimix OOC systems
      Learn more

      Consumables

      • Multi-chip plates
      • 3D validated cells
      • NASH-in-a-box
      Learn more

      Models

      • Single-organ models
      • Multi-organ models

      Support packages

      • PhysioMimix™ support packages
  • Applications
    • Discover the applications


      Investigate the application areas that our PhysioMimix™ products and services support

      Learn more

      Disease modeling

      • Non-Alcoholic Steatohepatitis
      • Hepatitis B
      • Oncology
      • COVID-19
      Learn more

      Safety toxicology

      • Drug-induced liver injury
      • Immune-mediated toxicities
      Learn more

      ADME

      • Drug absorption
      • Drug metabolism
      • Drug bioavailability
      Learn more
  • Services
    • Studies as a service


      Our team will work collaboratively with you to design a study around your research goals and generate actionable data within weeks

      Learn more
      NAFLD / NASH icons

      NAFLD / NASH

      Drug-induced liver injury icon

      Drug-induced liver injury

      icon adme |

      ADME

      Oncology icon

      Oncology

  • Resources
  • Company
    • About us


      Meet the team, explore our culture and discover what to expect when working with us

      CN Bio team photo
      About us

      Latest news

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

      • The U.S. FDA Modernization Act 2.0. Now the animal testing mandate is removed, learn what can be embraced in its place.

      • CN Bio appoints Dr Paul Brooks as Chief Executive Officer

      View all news

      Upcoming Events

      • SLAS2023

      • SOT 2023

      • WORD 2023

      • SLAS Europe 2023

      • MPS World Summit 2023

      View all events

      Join the team!

      View all jobs
  • Contact
  • Products
    • PhysioMimix™ OOC Microphysiological Systems
    • Consumables
      • PhysioMimix™ multi-chip plates
      • 3D validated cells
      • NASH-in-a-box
    • Organ-on-a-chip models
    • Support packages
  • Applications
    • Disease modeling
    • Safety toxicology
    • ADME
  • Services
    • Non-Alcoholic Steatohepatitis
    • Drug-Induced Liver Injury
    • ADME
  • Resources
  • Company
    • About us
    • Events
    • News
    • Careers
  • Contact
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
Chat live with an expert

CN Bio FDA collaboration expanded

May 5, 2021 by CN Bio

The FDA expands collaboration with CN Bio to investigate lung-on-a-chip model for inhaled drug evaluation applications


  • Extension aims to evaluate CN Bio’s PhysioMimix lung-on-a-chip platform in addition to deepening existing research collaboration for liver studies
  • Follows success of initial project demonstrating the advanced performance of the Company’s liver-on-a-chip platform

CN Bio, a leading developer of single- and multi-organ-on-chip microphysiological systems (MPS) that improve the accuracy and efficiency of drug discovery, today announced the U.S. Food and Drug Administration (FDA) has extended their research collaboration, for a further three 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 regulator1. 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.”


  1. ‘Characterizing 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

Learn more about CN Bio’s products and services

Category iconPress releases

Primary Sidebar

Other recent news

  • The FDA further expands collaboration with CN Bio to evaluate the PhysioMimix Multi-organ microphysiological system January 17, 2023
  • The U.S. FDA Modernization Act 2.0. Now the animal testing mandate is removed, learn what can be embraced in its place. January 9, 2023
  • CN Bio appoints Dr Paul Brooks as Chief Executive Officer December 19, 2022
  • Pharmacokinetics in mice… or a microfluidic device! August 3, 2022
  • CN Bio opens new laboratory facilities to extend Organ-on-a-chip contract research services capabilities July 19, 2022

Speak to our experts

Speak directly with one of our OOC experts to see how our products and services can support your studies

Request a meeting

Footer

CN Bio logo

332 Cambridge Science Park, Milton Road
Cambridge, CB4 0WN

+44 (0) 1223 737941

Privacy | Cookies | Terms | Regulatory | Accessibility

©2023 CN Bio Innovations Ltd
Registered No. ‍06517359. VAT No. 978184563

Latest news

  • The FDA further expands collaboration with CN Bio to evaluate the PhysioMimix Multi-organ microphysiological system January 17, 2023
  • The U.S. FDA Modernization Act 2.0. Now the animal testing mandate is removed, learn what can be embraced in its place. January 9, 2023
  • CN Bio appoints Dr Paul Brooks as Chief Executive Officer December 19, 2022

Upcoming events

MPS World Summit 2023 June 26-30, 2023

SLAS Europe 2023 May 22-26, 2023

SLAS2023 February 25 - March 1, 2023