생화학분자생물학회

	Name: Jangwook Lee ( jlee@kribb.re.kr )
	2021-present	Associate Professor, School of Bioscience, Korea University of Science and Technology, Daejeon, Republic of Korea
	2020-present	Associate Director, Biotherapeutics Translational Research Center, Korea Research Institute of Bioscience & Biotechnology, Daejeon, Republic of Korea
	2016-present	Principal Researcher, Biotherapeutics Translational Research Center, Korea Research Institute of Bioscience & Biotechnology, Daejeon, Republic of Korea
	2013-2016	Postdoctoral Associate, Center of Theragnosis, Korea Institute of Science and Technology, Seoul, Republic of Korea
	2009-2013	Ph.D., Department of Bioengineering, Hanyang University, Seoul, Republic of Korea

Redefining preclinical testing: human-relevant alternatives beyond animal models

Both ethical imperatives and scientific limitations increasingly challenge the traditional reliance on animal models for toxicity testing and drug evaluation, particularly in the era of precision medicine. In response, a paradigm shift is underway, marked by the development of advanced in vitro and in silico technologies that can offer human-relevant and mechanistically informed alternatives. This review examines well-established alternatives, such as receptor binding assays, the monocyte activation test, and enzyme-linked immunosorbent assays, highlighting their applications, mechanisms, and limitations. We further explore emerging human-relevant technologies that include organoids, organ-on-a-chip systems, micro-physiological systems, and artificial intelligence-powered modeling platforms. Special emphasis is placed on immune-integrated micro-physiological systems as next-generation platforms to evaluate immunotherapy, vaccine responses, and immune toxicities. These models recapitulate dynamic human physiological processes, such as hematopoiesis and germinal center reactions, beyond the capabilities of traditional animal systems. Collectively, these technologies represent scientifically superior and ethically progressive trajectories for preclinical testing. Their integration into regulatory and industrial workflows requires continued refinement, cross-sector collaboration, and standardization.


BMB Rep. 2025 Sep 16:6516. Online ahead of print.
https://pubmed.ncbi.nlm.nih.gov/40962329/