病毒类生物制品的滴度检测方法研究进展

Progress in research on the virus titration methods for viral biological products

病毒类生物制品包括病毒性疫苗以及用于基因治疗和肿瘤治疗的各种病毒载体药物,其研发和生产过程需要建立准确而快速的检测方法,用于评价工艺效果。滴度是检测病毒类生物制品活性和效力的直接数据佐证,也是评价生物制品质量的关键指标之一。此文主要对噬斑法、半数感染量测定法、荧光定量PCR技术、病变灶免疫化学法、报告基因法等病毒滴度检测方法的原理、特点及研究进展进行综述。

Viral biological products include viral vaccines and various viral vector drugs for gene therapy and oncolytic virotherapy.In the process of research and production,accurate and rapid assay methods should be established to evaluate the process and final products.Titer is essential for the detection of the viability and potency of viral biological products,and is one of the key indicators to evaluate the quality of biological products.This article mainly reviews the principles,characteristics and research progress of virus titration methods,including virus plaque formation assay,50%infectious dose measurement method,fluorescence quantitative polymerase chain reaction,plaque focus immunochemical method,and reporter gene assays.