摘要
病毒滴度测定是生物制药行业重要的分析方法,广泛应用于病毒类生物制品的开发和生产、病毒清除灭活工艺验证、外源病毒检测等领域,以确保病毒类生物制剂的活性和有效性,以及生物制品的病毒安全性。因此,建立快速、简单且准确的病毒滴定检测方法尤为重要。总结了检测病毒滴度的传统方法、新兴以及改良方法的特点、原理及具体应用,并比较了各自的优缺点。一些新兴方法,如微滴式数字PCR、病毒定量毛细管电泳、化学发光ISH-PNA测定、激光力细胞学等改进了传统方法耗时耗力、重复性差、准确性低、结果主观性大的缺点,达到了快速、灵敏、自动化程度高、精密度高、结果更加稳健且客观的优点,但部分新方法仪器昂贵或者未广泛使用,需要根据实验目的选择合适的病毒滴定方法。
Virus titration is an important analytical method in the biopharmaceutical industry,which is widely used in the development and production of viral biological products,the validation of virus clearance and inactivation processes,and the detection of exogenous viruses to ensure the activity and effectiveness of viral biologics,as well as the viral safety of biological products.It is important to establish a fast,simple,and accurate method for the detection of virus titration.This article summarized the characteristics,principles and specific applications of the traditional,emerging and improved methods for detecting viral titer and compared their advantages and disadvantages.Some emerging methods,such as droplet digital PCR,viral quantitative capillary electrophoresis,in situ hybridization(ISH) assay with chemiluminescent detection,laser force cytology,etc.,have improved the shortcomings of traditional methods such as time-consuming and labor-intensive,poor repeatability,low accuracy,and large subjectivity of results,and have achieved the advantages of rapidity,sensitivity,high degree of automation,high precision,and more robust and objective results.However,some new methods are expensive or not widely used,and it is necessary to select the appropriate virus titration method according to the experimental purpose.
作者
杜丽萍
徐明明
官艳东
周沙沙
张杰
DU Liping;XU Mingming;GUAN Yandong;ZHOU Shasha;ZHANG Jie(Testing Department of Sino Biological Inc.,Beijing 100176,China)
出处
《生物技术进展》
2024年第3期377-387,共11页
Current Biotechnology
关键词
生物制药
病毒清除/灭活验证
病毒感染性
病毒滴定
biopharmaceutical
viral clearance/inactivation validation
viral infectivity
virus titration
