Liver organoid to replace animal testing … Daewoong Pharmaceutical begins commercialization

A liver organoid platform, drawing attention as a next-generation toxicity assessment technology that could replace animal testing, has taken its first step toward commercialization. Developed through a research and development project by the Ministry of Food and Drug Safety, the technology has been transferred to Daewoong Pharmaceutical, laying the foundation for industrial use and international standardization.

On the 28th, the National Institute of Food and Drug Safety Evaluation, under the Ministry of Food and Drug Safety, announced that it had transferred a toxicity assessment liver organoid platform developed by a research team led by Dr. Myeong-jin Son of the Korea Research Institute of Bioscience and Biotechnology to Daewoong Pharmaceutical. The transfer was pursued to increase the technology’s utility in drug development and proactively establish a stable supply base in preparation for its future inclusion in international standards.

Liver organoids are cell models that replicate the structure and function of actual human liver tissue by culturing human stem cells in three dimensions. Because they can predict drug-induced liver toxicity more accurately than conventional 2D cell models, they are considered a non-animal method (NAM) that can reduce animal testing.

The transferred technology is distinguished by its ability to reproduce not only human liver tissue but also the structure responsible for bile excretion, further improving its ability to predict human responses. It can also be cultured over extended periods and retain its function after freezing and thawing, giving it significant potential for use beyond the laboratory and in industrial settings.

Daewoong Pharmaceutical will be responsible for the stable manufacture and supply of liver organoids, drawing on its drug research and development capabilities and manufacturing infrastructure. If the technology is adopted as an international standard, this is expected to play a key role in enabling the company to respond quickly to demand from industry in South Korea and abroad.

The Ministry of Food and Drug Safety is pursuing international standardization to list the technology as an official test guideline (TG) of the Organisation for Economic Co-operation and Development (OECD). If adopted as a guideline, the toxicity testing method using liver organoids would become the world’s first international standard of its kind. This would enable South Korean companies to submit data generated using the method to global regulatory agencies.

An MFDS official said, "This technology transfer is a representative success story in which research achievements have led to use in industry. Next-generation, human-centered toxicity assessment technology will improve the efficiency of drug development and contribute to strengthening the global competitiveness of South Korea’s biotechnology industry."