TissUse will join forces with Bayer to develop a novel mechanistic in vitro assay that will allow assessment of species differences of critical toxicities for early development and registration. Furthermore, the new assay is expected to significantly contribute to the 3R principles of animal welfare.
The assessment of human relevance of certain toxicities observed in animal assays still represents a major challenge for the various areas of toxicology (human & veterinary drug candidates, agrochemicals and industrial chemicals). A recurring problem is thyroid or testicular toxicity that occurs in both crop protection, as well as human and veterinary drug development candidates.
Answering whether toxicity findings in rodent lack human relevance as well as predicting human toxicities that are absent in rodent are key for risk assessment and regulatory success.
The project aims to establish a multi-organ-chip (MOC) based assay combining the target organs and liver in an integrated microfluidic system allowing for metabolic and endocrine interaction. This will enable researchers to differentiate between direct effects on the target tissues and indirect effects mediated by liver activation using an in vitro assay.
“We are thrilled to start this new collaboration, which will address a fundamental area of unmet need in safety assessment,” said Dr Uwe Marx, CEO of TissUse.
“We already have a long-standing relationship with Bayer and this new project will enable the development of an assay with potentially great predictive power for Bayer across divisions and businesses.”
TissUse's proprietary commercial MOC technology platform is a microfluidic microphysiological systems platform capable of maintaining and culturing miniaturised organ equivalents emulating the biological function of their respective full-size counterparts across long periods. Major features of living biology such as pulsatile fluid flow, mechanical and electrical coupling, physiological tissue-to-fluid and tissue-to-tissue ratios are incorporated.