生物制品中宿主细胞残留DNA检测技术进展  

Advances in residual host cell DNA detection technology in biopharmaceutical products

作　　者：马宁 黄峥梓昂 王腾苇 俞晓平 孙凯 叶子弘 MA Ning;HUANG Zheng-zi-ang;WANG Teng-wei;Y Xiao-ping;SUN Kai;YE Zi-hong(Zhejiang Provincial Key Laboratory of Biometrology and Inspection&Quarantine,College of Life Science,China Jiliang University,Hangzhou 310018,China;Key Laboratory of Microbiological Metrology,Measurement&Bio-product Quality Security,State Administration for Market Regulation,Hangzhou 310018,China)

机构地区：[1]中国计量大学生命科学学院浙江省生物计量及检验检疫技术重点实验室,杭州310018 [2]国家市场监督管理总局重点实验室(微生物计量检测与生物制品质量安全),杭州310018

出　　处：《药物分析杂志》2025年第2期181-194,共14页Chinese Journal of Pharmaceutical Analysis

基　　金：国家重点研发计划项目(2021YFF0600800);浙江省属高校基本科研业务费专项资金项目(2022YW04)。

摘　　要：近年来,生物技术领域的迅猛发展显著提升了生物制品在全球药品市场中的占比。同时,宿主细胞残留DNA(rcDNA)因潜在的传染性或致癌性,引发了广泛的关注。为了确保药品的安全性,多数生物制品需要在整个生产过程中严格监控,并证明rcDNA的清除。目前,常用的检测方法包括实时定量PCR(qPCR)法、微滴式数字PCR(ddPCR)法、DNA探针杂交法和荧光染色法等。这些技术各有优劣,并且在全面检测潜在rcDNA方面还存在一定的挑战。本文旨在探讨生物制品中rcDNA的潜在来源,并对现有的检测方法进行全面的综述,分析比较了各种方法的优势和不足,并对rcDNA检测技术的发展进行了展望,为生物制品中rcDNA的检测提供参考。In recent years,the rapid advancement of biotechnology has significantly increased the proportion of bioharmaceutical products in the global pharmaceutical market.Meanwhile,residual host cell DNA(rcDNA)has become a major concern due to its potential infectious or carcinogenic risks.To ensure the safety of biopharmaceuticals,most biological products require strict monitoring and proof of rcDNA clearance throughout the entire production process.Currently,commonly employed detection methods include real-time quantitative PCR(qPCR),droplet digital PCR(ddPCR),DNA probe hybridization,and fluorescent staining methods,among others.While these technologies each offer distinct advantages,they also face challenges in comprehensively detecting potential rcDNA.This review explores the potential sources of rcDNA in biopharmaceutical products and provides an in-depth evaluation of existing detection methods.It systematically analyzes and compares the strengths and limitations of various techniques,and discusses future directions for the development of rcDNA detection technologies.This work aims to offer valuable insights and references for improving the detection and control of rcDNA in biopharmaceutical production.

关 键 词：生物制品 宿主细胞 rcDNA 检测方法 

分 类 号：R917[医药卫生—药物分析学]