Commercial translation of a dynamic ADME screening platform,.DYNASCREEN.

The Caco-2 cell line used by the pharmaceutical industry and support companies is the gold standard for the prediction of drug absorption and permeability in vitro by mimicking the small intestine. However, this model lacks the dynamic motion which represents one of the physiological functions of the small intestine (peristalsis). Our new product developments using MICA technology investigate the possibility of improving the static Caco-2 cell model by creating a dynamic in vitro screening environment. Our results to dateas part of an Innovate funded Feasibility study have shown that MICA’ technology improves the absorption of the selected drugs, and their permeability is more similar to that found in the human intestine. Our data suggests that MICA’ technology applied to Caco-2 drug permeability assay could be used to a better predict, using in vitro assays, the in vivo human drug absorption rates. We are now at the stage of validation of our assay with a partner ADME contract research organisation (CRO) before commercialisation of our product. This project will enable us to create the final QA steps and the validation of the assay in an ADME CRO environment using validated drug compounds. The final stages will include creation of standard operating procedures (SOPs) alligned to the existing assay and design of new QA steps for the protocol.