CN Bio releases new in vitro DILI assay kit for toxicology screening
CN Bio has launched an all-in-one drug-induced liver injury (DILI) testing kit that enables pharmaceutical researchers to conduct in-house hepatotoxicity screening using organ-on-chip technology. The system provides human-relevant data to support more informed candidate selection during preclinical development.
Addressing a critical development bottleneck
Despite advances in preclinical testing methodologies, hepatotoxicity remains a significant cause of drug candidate failure, responsible for approximately 18% of clinical trial terminations. Current assessment approaches rely on a combination of in vitro assays, animal studies and computational modelling, each with inherent limitations regarding physiological relevance and clinical translatability.
The newly launched PhysioMimix DILI assay kit: Human 24 has been developed to overcome these constraints by providing a standardised microphysiological system (MPS) that more accurately replicates human liver function in vitro. Previously only available through the company’s contract research services, this technology has now been refined into a kit format to enable broader adoption within drug development laboratories.
Technical specifications and capabilities
The system utilises primary human hepatocytes maintained under continuous perfusion for up to two weeks, creating metabolically active hepatic tissues. A key feature of the model is the incorporation of Kupffer cells, which introduces an innate immune component that enables assessment of more complex toxicological pathways over extended timeframes.
Each kit provides 24 wells, allowing researchers to evaluate up to eight conditions in triplicate simultaneously. This throughput supports comparative analysis of multiple compounds or concentrations, facilitating more comprehensive risk assessment during candidate selection.
The MPS platform has been recognised by the FDA and extensively characterised for reproducibility in assessing drug toxicity, metabolism and accumulation, as documented in peer-reviewed literature.
Dr Ovidiu Novac, Senior Scientist and Project Manager at CN Bio, explained the rationale behind developing the kit: “Toxicology testing is perhaps the most essential part of developing a new drug, but our current preclinical methods often fall short, putting therapeutic developers at risk of extremely costly, late-stage failures. Previously available via our CRS, we chose to further develop our DILI assay into a simple, all-in-one kit, in response to increasing demand for human-relevant, preclinical toxicology testing. With Human 24, PhysioMimix users can now more easily replicate our industry-leading DILI assay in their own lab, providing deeper mechanistic insights into drug-induced hepatoxicity and enabling more confident progression of drug candidates into the clinic.”
Benefits for emerging therapeutic modalities
The system’s utilisation of human primary cells provides particular advantages for developers of novel therapeutic modalities, including biologics, oligonucleotides and cell therapies, where traditional animal models often lack relevant targets or pathways.
By streamlining implementation of organ-on-chip technology, the kit removes barriers associated with MPS model development and validation, allowing research organisations to rapidly integrate this advanced screening platform into existing workflows without extensive optimisation.
The physiological relevance of the system potentially offers several advantages over conventional hepatotoxicity assays, including:
• Detection of metabolite-mediated toxicity through maintained Phase I/II enzyme activity
• Assessment of immune-mediated hepatotoxicity mechanisms via Kupffer cell interactions
• Evaluation of cumulative toxicity through extended culture periods
• Analysis of complex dose-response relationships in a more physiologically representative environment
These capabilities support more informed decision-making during lead optimisation and candidate selection phases, potentially reducing late-stage attrition due to hepatotoxicity issues that might otherwise remain undetected until clinical trials.
For more information, visit: www.cn-bio.com
Digital issue: Please click here for more information
Dr Ovidiu Novac, Senior Scientist and Project Manager (DILI assay kit), CN Bio
