The Ministery of Food and Drug Safety-supported research and development on a human-based liver Organoid (mini organ) toxicity assessment technology has been transferred to Daewoong Pharmaceutical(069620). With the U.S. Food and Drug Administration (FDA) and countries worldwide moving to reduce animal testing and expand alternative test methods, Korea is expected to see full-fledged industrialization of related technologies.
The National Institute of Food and Drug Safety Evaluation (NIFDS) under the Ministery of Food and Drug Safety said on the 15th that the "liver Organoid platform for toxicity assessment," developed through a Ministery of Food and Drug Safety research project, was transferred to Daewoong Pharmaceutical.
The technology transferred this time was developed by a research team led by Dr. Son Myeong-jin at the Korea Research Institute of Bioscience and Biotechnology (KRIBB). It is a platform that produces and cultures liver Organoids using human stem cells and uses them to evaluate drug toxicity.
A liver Organoid is a three-dimensional cell model that reproduces the structure and function of actual human liver tissue. It can predict drug-induced liver injury in humans more accurately than conventional two-dimensional hepatocytes and is drawing attention as a next-generation testing method (NAMs) to replace animal studies.
According to the Ministery of Food and Drug Safety, this platform not only reproduces liver tissue but also the bile excretion structure to improve predictivity for humans, and its functions are maintained even after long-term culture or freeze-thaw cycles, enabling repeated toxicity testing and use in industrial settings.
The Ministery of Food and Drug Safety is also pushing to standardize the technology internationally so it can be adopted as an Organization for Economic Cooperation and Development (OECD) test guideline. If adopted as an OECD test guideline, test methods developed in Korea can be submitted to regulatory agencies around the world. The Ministery of Food and Drug Safety expects that if a toxicity testing method using liver Organoids is adopted, it would be the first case in the world.
Daewoong Pharmaceutical plans to use this technology to evaluate liver toxicity of candidate substances early in the new drug research and development process and, if OECD test guidelines are established, to stably manufacture and supply liver Organoids to expand their use in industry.
The Ministery of Food and Drug Safety said, "This technology transfer is a representative case of government research and development outcomes being used in real-world industrial settings beyond the laboratory," and added, "We will continue to promote the development of human-centered animal alternative test methods and OECD international standardization to improve the accuracy of new drug safety assessments and help strengthen the global competitiveness of Korea's bio and pharmaceutical industries."