This method offers a more accurate and ethical approach to pharmaceutical drug testing.
Researchers at King’s College London (KCL) have created a lab-grown mini-liver model that promises new, more effective and ethical methods for pharmaceutical drug testing.
This approach, uniquely engineered by combining hepatocytes with synthetic nanoscaffolds, offers a promising alternative to animal models for preclinical drug screening and toxicity testing.
For decades, animal models have been used in drug discovery to test the safety of new drug candidates, but they pose several ethical concerns and practical challenges, including physiological differences between animals and humans, high costs, and tissue availability.
Healthcare regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency are encouraging the increased use of non-animal models in drug discovery and development.
The FDA Modernization Act 2.0, promulgated in 2023, will allow alternatives to animal testing in drug and biologics applications.
The liver plays a key role in drug development as it is the primary site of drug metabolism. However, a significant issue is drug-induced liver injury, which can cause toxic side effects and lead to acute liver failure and drug discontinuation in clinical trials.
To address this challenge, mini-livers, created in the lab of Dr Bahija Raimi Abraham, Senior Lecturer in Pharmaceutical Sciences at KCL, are designed to mimic the structure and function of the human liver more accurately than traditional 2D cell culture models.
The results were announced ACS Applied Materials and Interfaces The mini-livers cultured in the lab showed superior cell assembly and liver replication, as well as enhanced drug metabolism capacity, compared with other mini-liver models that did not use nanoscaffolds.
The model “not only addresses ethical concerns associated with animal testing by accurately replicating human liver function, but also has the potential to replace animal testing in drug screening by providing a more reliable platform for evaluating drug safety and efficacy,” Raimi-Abraham said.
The team also plans to apply the technique to develop models of other organs to model specific infectious diseases, such as malaria.
