细胞治疗产品的生物分布研究进展  

Progress in researches for biodistribution studies on cell therapy products

作　　者：钟小群 张亚群 闫振龙 钱庄 胡文元 胡静 陈晓俊 李一昊 吕建军 李华 ZHONG Xiao-qun;ZHANG Ya-qun;YAN Zhen-long;QIAN Zhuang;HU Wen-yuan;HU Jing;CHEN Xiao-jun;LI Yi-hao;LV Jian-jun;LI Hua(InnoStar Bio-tech Nantong Co.,Ltd.,Nantong 226133,China)

机构地区：[1]益诺思生物技术南通有限公司,南通226133

出　　处：《中国新药杂志》2022年第19期1888-1894,共7页Chinese Journal of New Drugs

基　　金：江苏省新药一站式高效非临床评价公共服务平台建设项目(BM2021002)。

摘　　要：细胞治疗产品(cell therapy products,CTPs)的生物分布信息对于预测和评估其在非临床和临床研究中的药效和毒性作用特征至关重要。要进行细胞治疗产品的生物分布研究,必须了解其监管要求、实施状况和主要分析方法。本文简要介绍了国内外细胞治疗产品的生物分布研究相关监管指南或指导原则中关于生物分布研究的目的、时间安排和推荐方法,如定量聚合酶链反应(quantitative polymerase chain reaction,qPCR)和基于成像技术方法,包括正电子发射断层成像(positron emission tomography,PET)、单光子发射计算机断层成像(single photon emission computed tomography,SPECT)、磁共振成像(magnetic resonance imaging,MRI),以及生物发光成像(bioluminescence imaging,BLI)等方面的研究进展,旨在为我国细胞治疗产品的生物分布研究提供一定的参考。The biodistribution information of cell therapy products(CTPs)is essential for prediction and assessment of their efficacy and toxicity profiles in non-clinical and clinical studies.To conduct biodistribution studies on CTPs,it is necessary to understand regulatory requirements,implementation status,and main analytical methods.The article gives a brief introduction of the progress in researches in relevant regulatory guidelines or guidances in a global setting for the purpose,timing,recommended methods,such as quantitative polymerase chain reaction(qPCR),and imaging-based methods which include positron emission tomography(PET),single photon emission computed tomography(SPECT),magnetic resonance imaging(MRI),as well as bioluminescence imaging(BLI),in order to provide some references for the biodistribution studies of CTPs in China.

关 键 词：细胞治疗产品 生物分布 监管指南 定量聚合酶链反应 基于成像技术方法 

分 类 号：R969.1[医药卫生—药理学]