Risk management and technical considerations on donor screening for cellular therapy products
LIU Dan
JIA Dong-chen
CUI Jing
WEI Wei
Abstract：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.
Keywords：cellular therapydonor screeninginfectious pathogenrisk management
Publication Date：2023-12-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2489-2494 )