细胞治疗产品供者筛查的风险控制与技术考虑

Risk management and technical considerations on donor screening for cellular therapy products

我国细胞治疗产业发展迅猛。随着越来越多的细胞治疗产品实现商业化,对此类产品的安全性及有效性提出了更高的要求。供体材料作为细胞治疗产品的关键起始原材料,其质量直接影响到细胞产品的安全性和质量可控性,因此供者筛查的风险控制至关重要。其中,传染性病原体筛查是细胞疗法病毒安全性及生物安全的重要保障。目前,行业尚未针对供者筛查质量管理体系形成统一的标准或共识,监管框架尚待逐步完善。本文就当前供者筛查的难点与挑战、总体风险控制策略以及传染性病原体检测技术考虑进行探讨与分析,并梳理汇总国内外相关监管指南及要求,以期为后续细胞治疗供者筛查的标准化、规范化及监管要求制定提供借鉴和参考。

Cellular therapy industry is booming in China.As increasing cellular therapy products are authorized and commercialized,hence higher requirements are set for the safety and efficacy of cellular therapy.As the essential starting raw material,the quality of donor materials directly affects the safety and quality of cell products,thus,the risk management of donor screening is crucial.Herein,the screening of infectious pathogens is a vital guarantee for the viral safety and biosafety of cellular therapeutics.Currently,no uniform standards or consensus have been reached for donor screening quality management system,thus the regulatory framework needs to be further supplemented.This paper discusses the current obstacles and challenges in donor screening,overall risk management strategies and technical considerations on infectious pathogen detection,and meanwhile reviews the relevant regulatory guidelines and requirements at home and abroad,aiming to provide reference for subsequent standardization and regulatory requirements for donor screening in cellular therapeutics.