Cellular and Tissue Therapy Branch, Office of Therapeutic Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Department of Biomedical Engineering, University of Delaware, Newark, DE 19711, USA.
Exp Biol Med (Maywood). 2023 Nov;248(22):2001-2019. doi: 10.1177/15353702231215897. Epub 2024 Jan 2.
There is a need for better predictive models of the human immune system to evaluate safety and efficacy of immunomodulatory drugs and biologics for successful product development and regulatory approvals. Current models, which are often tested in two-dimensional (2D) tissue culture polystyrene, and preclinical animal models fail to fully recapitulate the function and physiology of the human immune system. Microphysiological systems (MPSs) that can model key microenvironment cues of the human immune system, as well as of specific organs and tissues, may be able to recapitulate specific features of the inflammatory response. This minireview provides an overview of MPS for modeling lymphatic tissues, immunity at tissue interfaces, inflammatory diseases, and the inflammatory tumor microenvironment and . Broadly, these systems have utility in modeling how certain immunotherapies function , how dysfunctional immune responses can propagate diseases, and how our immune system can combat pathogens.
需要更好的人类免疫系统预测模型,以评估免疫调节药物和生物制剂的安全性和疗效,从而成功进行产品开发和监管审批。目前的模型通常在二维(2D)聚苯乙烯组织培养物和临床前动物模型中进行测试,无法完全再现人类免疫系统的功能和生理学。微生理系统(MPS)可以模拟人类免疫系统以及特定器官和组织的关键微环境线索,可能能够再现炎症反应的特定特征。这篇迷你评论概述了用于模拟淋巴组织、组织界面免疫、炎症性疾病和炎症肿瘤微环境的 MPS。广义而言,这些系统可用于模拟某些免疫疗法的作用方式、功能失调的免疫反应如何引发疾病以及我们的免疫系统如何对抗病原体。