Under the terms of the collaboration agreement, 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.

MOC-based liver-endocrine tissues assay to bridge the gap between animal and human safety assessment

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 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,” says 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.”

About the Multi-Organ-Chip (MOC) technology

TissUse proprietary commercial MOC technology platform is a microfluidic microphysiological systems platform capable of maintaining and culturing miniaturized organ equivalents emulating the biological function of their respective full-size counterparts over 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. This supports the development of a large variety of substance test assays ranging from acute and repeated dose toxicity to long-term disease treatment (efficacy). The technology allows for flexible and customized combination of different tissue constructs or organ equivalents on a disposable chip-based microphysiological system. The number of organ equivalents supported by the platform ranges from single organ culture up to an organ number supporting the study of complex organ interactions. First commercially available platforms support single-, two-, three and four-organ culture. Examples of organ models available at TissUse include: liver, intestine, skin, vasculature, neuronal tissue, cardiac tissue, cartilage, pancreas, kidney, hair follicle, lung tissue, fatty tissue, tumor models and bone marrow. Further organ models are being developed. The platform further comprises Control Units operating up to four MOCs simultaneously. These Control Units provide the flexibility needed to control and monitor any on-chip organ arrangement. Some of the existing models include different levels of immunocompetence such as immune cells in skin biopsies, Langerhans cells in full-thickness skin equivalents, hematopoietic progenitor cells in the bone marrow model and Kupffer cells in liver spheroids.