Liver-Chip drug development tool
The FDA Center for Drug Evaluation and Research has marked a major milestone by accepting the first organ-on-a-chip technology into its Innovative Science and Technology Approaches for New Drugs (ISTAND) Program. This program promotes the use of innovative tools to improve how new drugs are developed. The accepted technology, called the Liver-Chip, is an MPS designed to predict drug-induced liver injury (DILI), a common reason drugs fail during early testing.
The Liver-Chip recreates the human liver environment by growing four types of liver cells in a small, engineered device. These cells mimic the natural physiology and mechanical forces they experience in the human body. This setup allows scientists to monitor in real time how drugs may cause liver damage compared to safe conditions. Importantly, the Liver-Chip evaluates whether a drug poses less, similar, or more risk of liver injury than other drugs in the same class. By improving preclinical testing, it can provide better data for drug investigational submissions and can help identify safer treatments earlier in development.
Initial Liver-Chip assessment has revealed the following:
- Conventional toxicity assays do not perform well in liver MPS.
- ALT activity is not stable in the Liver-Chip.
- Lactate dehydrogenase activity is prone to interference by medium components.
- ELISA is recommended for toxicity measurement in liver MPS.
- The chemical method is recommended for the urea assay in the Liver-Chip, offering adequate and improved specificity and sensitivity.
These results highlight the importance of reliable and reproducible assays for translational DILI biomarkers in liver MPS. Work is ongoing, demonstrating FDA’s commitment to advancing new technologies, such as organ-on-a-chip systems, that have the potential to bring safer and more effective therapies to patients while reducing reliance on animal testing.