CN Bio launches PhysioMimix Bioavailability assay kit: Human 18

• Unique solution enabling researchers to profile human oral drug bioavailability in vitro, in their own laboratories
• Expands access to CN Bio’s robust multi-organ Gut/Liver-on-a-chip model to accelerate and de-risk clinical progression of drug candidates
• Supports up to 18 data replicates and simulation of both intravenous and oral dosing routes

Estimating bioavailability is an essential part of preclinical drug development and necessary to inform safe and effective dosage in the clinic. Currently, human drug bioavailability is estimated by combining several data sources, including in vitro assays, in vivo animal studies, and in silico modelling. Each of these have distinct drawbacks; with in vitro and 2D cell cultures unable to account for the complexity of drug absorption, and animal models having significant differences in physiology and metabolic capacity that limit data translatability into humans¹.

The kit has been developed following the successful launch of CN Bio’s PhysioMimix Bioavailability assay into its ADME Contract Research Service offerings in January 2024, in response to market demand for a novel approach to address the limitations of traditional methods. The Company has refined the assay into an easy-to-use kit format, enabling customers to rapidly onboard and recreate the assay in their own labs. The Bioavailability assay kit: Human 18 is optimized for use with the Company’s PhysioMimix^® Multi-organ System, uniquely bridging the gap between in vitro and in vivo studies to enable accurate and predictive profiling of human oral drug bioavailability earlier in the drug development process. It enables researchers to select and progress only the most promising therapeutic candidates, better inform in vivo study design, and minimize the number of animals required.

CN Bio’s Bioavailability assay harnesses the Company’s robust Gut/Liver-on-a-chip model (also known as a Gut/Liver microphysiological system), developed in partnership with Altis Biosystems. Leveraging the organ-specific expertise of each company, it fluidically links two human-derived and highly characterized models: Altis Biosystems’ RepliGut^® Jejunum model and CN Bio’s FDA-recognized PhysioMimix Liver-on-a-chip, into one complete system. This dual-organ model accurately recapitulates key processes that determine bioavailability, including intestinal absorption, intestinal metabolism and hepatic clearance. Uniquely, it also enables users to simulate both intravenous and oral dosing routes, by assessing the models separately or as a combined system.

Dr Yassen Abbas, Lead Scientist, CN Bio, said: “Human bioavailability is a crucial part of choosing which drug candidates to progress to the clinic, but an area that is notoriously poorly served by existing models. The PhysioMimix Bioavailability assay kit: Human 18 effectively tackles this issue, providing up to 18 replicates for our customers to profile their drug candidates in vitro, minimizing risk and maximizing the chance of clinical success. The kit modernizes workflows by removing the burden of assay development and validation, so researchers can rapidly onboard an OOC approach.”

“Recognizing the distinct market demand for new solutions to more accurately predict human bioavailability, we are pleased to be partnering with CN Bio to combine the benefits of our industry leading single-organ models into a perfused and metabolically capable Gut/Liver-on-a-chip model.” said Dr Ben Scruggs, CEO, Altis Biosystems: “The Bioavailability assay kit: Human 18 allows users to harness the model’s capabilities from their own labs for the first time, providing a streamlined route to access predictive human data through an easy-to-use in vitro model.”

1. Musther, H. et al. (2014) ‘Animal versus human oral drug bioavailability: Do they correlate?’, European Journal of Pharmaceutical Sciences, 57, pp. 280–291
2. Press Release (23^rd January 2024): CN Bio and Altis Biosystems partner to develop next-generation human Gut/Liver in vitro model for advanced ADME studies