类器官技术在新药研发中的应用

Application of Organoid Technology in New Drug Research and Development

2022年,美国参议院通过《美国食品药品监督管理局现代化法案2.0》,再一次掀起了对动物试验代替方案的热议。类器官技术被认为是目前最有潜力的可代替动物试验的方案。自2007年Hans Clevers首次成功从小肠上皮细胞培育出类器官以来,类器官技术已有超过15年的发展历史,特别是在近些年,这项技术的相关研究迅速增长。目前,类器官技术仍存在待攻克的技术挑战和待补充的监管空白,类器官相关产业链尚处于形成期,基于类器官的各种应用方向的商业化道路仍在探索中。综述了类器官的研究历史、应用现状与挑战,并探讨其商业化前景,旨在帮助读者快速了解类器官技术的过去、现在与未来,以及为评估类器官技术在新药研发中的应用与商业价值提供参考。

With the passing of the FDA Modernization Act 2.0 by the U.S.Senate,there has been a renewed debate about alternatives to animal testing.Organoid technology is considered to be the most promising alternative to animal testing.The technology has a development history of over 15 years since Hans Clevers first cultivated organoids from small intestinal epithelial cells in 2007.In recent years,research on organoid technology has grown rapidly.Currently,organoid technology still faces unresolved technical challenges,and there are regulatory gaps that need to be supplemented.The industries related to organoid technology are still in the early stage,with ongoing exploration of its practical use and commercialization.This article reviews the research history,application status and challenges of organoids,then discusses their commercialization prospects,aiming to inform readers about the past,present and future of organoids technology,and to provide references for evaluating the application and commercial value of organoids technology in the development of new drugs.