Review & Monography

Advances in residual host cell DNA detection technology in biopharmaceutical products*

  • MA Ning ,
  • HUANG Zheng-zi-ang ,
  • WANG Teng-wei ,
  • YU Xiao-ping ,
  • SUN Kai ,
  • YE Zi-hong
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  • 1. Zhejiang Provincial Key Laboratory of Biometrology and Inspection & Quarantine, College of Life Science, China Jiliang University, Hangzhou 310018, China;
    2. Key Laboratory of Microbiological Metrology, Measurement & Bio-product Quality Security, State Administration for Market Regulation, Hangzhou 310018, China;

Received date: 2024-08-16

  Online published: 2025-08-25

Abstract

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.

Cite this article

MA Ning , HUANG Zheng-zi-ang , WANG Teng-wei , YU Xiao-ping , SUN Kai , YE Zi-hong . Advances in residual host cell DNA detection technology in biopharmaceutical products*[J]. Chinese Journal of Pharmaceutical Analysis, 2025 , 45(2) : 181 -194 . DOI: 10.16155/j.0254-1793.2024-1052

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