General considerations for the CMC research of immune cell therapy products during the investigational new drug
CHEN Chao
XU Hui-nan
PAN Jing
SHEN Bo
Abstract：Immune cell therapy products have demonstrated favorable therapeutic outcomes in the treatment of certain tumors.This article briefly descibes the application status of immune cell therapy products in China.By combining the pharmaceutical issues in investigational new drug(IND)applications and the common issues in regulatory communications for such products,and with reference to relevant domestic and international regulations as well as technical guidelines,it exemplifies the general considerations for pharmaceutical research in IND applicaitons of immune cell therapy products,focusing mainly on raw materials for production(cells for production,in vitro modification systems,and other raw materials for production),manufacturing processes,and quality research and control,in order to provide a reference for the research,development,and application of such products and to promote their clinical translation.
Keywords：immune cell therapy productsinvestigational new drugraw materialsproduction processesquality research and control
Publication Date：2026-06-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 1145-1151 )