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Review Article

Korean J Physiol Pharmacol 2020; 24(6): 441-452

Published online November 1, 2020 https://doi.org/10.4196/kjpp.2020.24.6.441

Copyright © Korean J Physiol Pharmacol.

Trends in the development of human stem cell-based non-animal drug testing models

Su-Jin Lee and Hyang-Ae Lee*

Department of Predictive Toxicology, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology, Daejeon 34114, Korea

Correspondence to:Hyang-Ae Lee
E-mail: vanessa@kitox.re.kr

Received: August 18, 2020; Revised: August 31, 2020; Accepted: August 31, 2020

This is an Open Access journal distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.


In vivo animal models are limited in their ability to mimic the extremely complex systems of the human body, and there is increasing disquiet about the ethics of animal research. Many authorities in different geographical areas are considering implementing a ban on animal testing, including testing for cosmetics and pharmaceuticals. Therefore, there is a need for research into systems that can replicate the responses of laboratory animals and simulate environments similar to the human body in a laboratory. An in vitro two-dimensional cell culture model is widely used, because such a system is relatively inexpensive, easy to implement, and can gather considerable amounts of reference data. However, these models lack a real physiological extracellular environment. Recent advances in stem cell biology, tissue engineering, and microfabrication techniques have facilitated the development of various 3D cell culture models. These include multicellular spheroids, organoids, and organs-on-chips, each of which has its own advantages and limitations. Organoids are organ-specific cell clusters created by aggregating cells derived from pluripotent, adult, and cancer stem cells. Patient-derived organoids can be used as models of human disease in a culture dish. Biomimetic organ chips are models that replicate the physiological and mechanical functions of human organs. Many organoids and organ-on-a-chips have been developed for drug screening and testing, so competition for patents between countries is also intensifying. We analyzed the scientific and technological trends underlying these cutting-edge models, which are developed for use as non-animal models for testing safety and efficacy at the nonclinical stages of drug development.

Keywords: In vitro model, Non-clinical testing, Organ-on-a-chip, Organoid, Stem cell