病毒类产品感染性滴度检测方法研究进展  

Advances in the Detection Methods of Infectious Titers in Viral Products

作　　者：田清雅 王自强 邵泓 TIAN Qingya;WANG Ziqiang;SHAO Hong(School of Pharmacy,Fudan University,Shanghai 201203;NMPA Key Lab.for Quality Control of Therapeutic Monoclonal Antibodies,Shanghai Institute for Food and Drug Control,Shanghai 201203)

机构地区：[1]复旦大学药学院,上海201203 [2]上海市食品药品检验研究院,国家药品监督管理局治疗类单抗质量控制重点实验室,上海201203

出　　处：《中国医药工业杂志》2024年第11期1485-1492,共8页Chinese Journal of Pharmaceuticals

摘　　要：病毒载体类疫苗产品、经慢病毒转导的CAR-T产品和以腺相关病毒为载体的基因治疗产品等病毒类产品种类的不断增加,产品的多样性和生产方式的复杂化,给生产单位和监管机构的质量控制和监督管理带来了新的挑战。针对病毒类产品,需要在生产和放行过程中对其纯度和活性等进行检验。感染性滴度作为病毒类产品的关键质量属性之一,在评估病毒类产品的安全性和有效性方面具有重要作用。该文主要总结了现有病毒感染性滴度定量方法的原理和应用,其中包括蚀斑法、半数组织培养感染量、荧光灶法、各类聚合酶链式反应、流式细胞术、纳米流式细胞术等。通过对这些方法进行介绍和比较,有利于生产企业和监管机构在不同的应用情况下选择合适的方法确保产品质量。The continuous proliferation of viral products,such as viral vector vaccines,CAR-T products produced by lentiviral transduction,and adenovirus-based gene therapy products,has presented novel challenges for manufacturing units and regulatory agencies in terms of quality control and supervision due to the complexity of production methods and diversity of products.To ensure the purity,activity,and other quality attributes of viral products,it is imperative to conduct inspections during the production and release processes.The infectious titer,as one of the key quality attributes,holds significant importance as it allows for the evaluation of safety and efficacy.This review provides a comprehensive summary of the principles and applications of existing methods for quantifying virus infectivity,including plaque assay,50%tissue culture infectious dose,fluorescent focus assay,various polymerase chain reactions,flow cytometry,and nano-flow cytometry(nFCM).By introducing and comparing these methods,manufacturing companies and regulatory agencies can make informed decisions regarding the selection of appropriate techniques to ensure product quality in different application scenarios.

关 键 词：病毒类产品 感染性病毒 滴度检测 研究进展 

分 类 号：Q93-33[生物学—微生物学] Q782