免疫细胞治疗产品新药临床试验申请药学研究的一般考虑

General considerations for the CMC research of immune cell therapy products during the investigational new drug

摘要

免疫细胞治疗产品已在部分肿瘤治疗中取得了良好的疗效。本文简述了我国免疫细胞治疗产品申报情况,并结合此类产品在临床试验申报资料中的药学问题和在沟通交流中的常见问题,参考国内外相关法规和技术指导原则等,重点从生产用原材料(生产用细胞、体外修饰系统、其他生产用原材料)、生产工艺、质量研究与控制方面举例说明了免疫细胞治疗产品新药临床试验申请药学研究的一般考虑,以期为此类产品的研发和申报提供一定参考,促进其临床转化。

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.

关键词

免疫细胞治疗产品 / 新药临床试验申请 / 生产用原材料 / 生产工艺 / 质量研究与控制

Key words

immune cell therapy products / investigational new drug / raw materials / production processes / quality research and control

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