细胞治疗产品的产业化发展探讨  

Discussion about the industrialization of cell therapy products

作　　者：冯强 杨晓彤 刘帅[2] 

机构地区：[1]清华大学工业工程系,北京100084 [2]京东方科技集团股份有限公司,北京100176

出　　处：《中国医药生物技术》2025年第1期101-106,共6页Chinese Medicinal Biotechnology

摘　　要：近年来,以干细胞治疗和免疫细胞治疗为代表的细胞治疗成为备受关注的新一代治疗技术,为癌症、退行性病变等难治性疾病带来了新希望。在细胞治疗技术迅速发展的同时,细胞治疗产品的产业化成为其当下及未来发展的重要课题。本文从细胞治疗的监管政策、产业链结构、产业化现状、产业发展中面临的挑战及解决思路等方面进行了综述,阐述了借助细胞生物学、人工智能、物联网技术,通过开发通用型、货架型产品提升产品可及性及通过自动化、规模化生产提升细胞产品质量均一性对细胞治疗产品产业化的重要意义,对细胞治疗的产业化发展方向进行了展望。In recent years,cell therapy,including stem cell therapy and immune cell therapy,has emerged as an innovative treatment technology that has attracted significant attention.It provides new hope for patients with cancer,degenerative diseases,and other serious illnesses.With the rapid advancement of cell therapy technology,the industrialization of cell products has become a key focus for both current and future development.This paper gives an overview of regulatory policies,the structure of the industrial chain,the current status of industrialization efforts in the field of cell therapy,and identifies challenges faced during industrial development along with potential solutions.Additionally,it highlights the importance of enhancing product accessibility through universal off-the-shelf products and improving quality uniformity through automation and large-scale production to facilitate the industrialization process,with the support of cell biology,artificial intelligence,and Internet of Things technology.Finally,this paper offers a forward-looking perspective on the future direction of industrial development in cell therapy.

关 键 词：细胞治疗 产业化 货架型产品 自动化生产 人工智能 

分 类 号：Q813[生物学—生物工程]