关于自体CAR-T细胞制品药学部分申报资料的共识性建议
Consensus Recommendations on Submitting Documentation for the Manufacturing and Controls for CAR-T Cell Products
李建平 1王冲 1于玲莉 1付秋雁 1谭建新 1陈尧水2
作者信息
- 1. 上海药品审评核查中心生物组,上海201203
- 2. 上海市食品药品监督管理局,上海200003
- 折叠
摘要
近年来,随着人们对免疫学理论技术的深入探索,免疫细胞治疗领域发展迅速.嵌合抗原受体T细胞(chimeric antigen receptor T-cell,CAR-T)制品,由于其在抗肿瘤方面所取得的显著效果,己从早期的基础研究逐步应用于临床治疗.为积极推进CAR-T细胞制品的研发注册进程,我中心借鉴国内外相关指导原则,经过前期调研及关键技术要点研讨,撰写了 《CAR-T细胞制品注册申报及生产指南建议稿》的初稿,并借助众多上海领先的CAR-T细胞研发生产企业及相关领域专家的技术力量对该稿进行充分讨论,提炼出业界对于CAR-T细胞制品(自体)药学部分普遍的研究关注点,最终达成以下共识性建议(药学版块研究资料),以供业界参考.
Abstract
During recent years,the field of immune-cell therapy has been rapidly developed with the studies of immunological theory and technology.CAR-T therapy,firstly developed as a basic research,has gradually transformed into clinical application and is becoming one of the most promising therapeutic strategies in cancer treatment.In China,regulations on immune-cell therapy is still underway,which could hinder its further development and clinical application.Therefore,aiming at promoting CAR-T cell research and registration process,we harnessed the expertise of leading researchers,closely studied the key technologies and took reference from relevant regulatory experiences for the first draft of "Proposal Guidelines for Registration and Manufacturing of CAR-T Cell Products".In this review,we will discuss the consensus recommendations on submitting documentation for the manufacturing and controls for CAR-T cell products.
关键词
CAR-T细胞制品(自体)/药学研究/申报资料/药品监管Key words
autologous CAR-T cell products/pharmacological study/drug dossier/drug regulation引用本文复制引用
出版年
2018
NETL
NSTL
维普
万方数据