Special Requirements and Considerations for Pre-Marketing Registration Testing of CAR-T Cell Therapy Products
WU Xueling1,2,3,4, XU Chongfeng1,2,3,4, LI Guoya1,2,3,4, FAN Shanshan1,2,3,4, JIA Chuncui1,2,3,4, DONG Siguo1,2,3,4, JIN Yuxuan1,2,3,4, MENG Shufang 1,2,3,4*
Pre-marketing registration testing of pharmaceuticals is one of the key links in China’s pharmaceutical supervision. Compared with other biological products, autologous CAR-T cell therapy products have particularities in production process and quality control due to restrictions such as their autologous product characteristics and the timeliness of patient medication, which also makes registration testing face many unique challenges. This article systematically summarizes the completed registration testing of autologous CAR-T products in recent years, conducts an in-depth analysis of the challenges faced by autologous CAR-T cell registration testing in terms of product characteristics, production process, sample timeliness and supervision under the current regulatory requirements as well as the corresponding solutions, systematically sorts out the problems identified in registration testing, including those related to quality standards, method development and validation, and deeply discusses the importance of pre-test communication, core communication content, as well as key points related to method transfer and verification. It aims to provide references for researchers and developers in the registration testing of such products and promote the standardized marketing process of the products.
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