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Advances in residual host cell DNA detection technology in biopharmaceutical products
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Ning MA1, Zheng-zi-ang HUANG1, Teng-wei WANG1, Xiao-ping YU1, 2, Kai SUN1, 2, **, Zi-hong YE1, 2, **
Chinese Journal of Pharmaceutical Analysis | 2025, 45(2) : 181 - 194
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Chinese Journal of Pharmaceutical Analysis | 2025, 45(2): 181-194
• Review & Monography •
Advances in residual host cell DNA detection technology in biopharmaceutical products
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Ning MA1, Zheng-zi-ang HUANG1, Teng-wei WANG1, Xiao-ping YU1, 2, Kai SUN1, 2, **, Zi-hong YE1, 2, **
Affiliations
  • 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
Published: 2025-02-28 doi: 10.16155/j.0254-1793.2024-1052
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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.

biopharmaceutical products  /  host cells  /  rcDNA  /  detection methods
Ning MA, Zheng-zi-ang HUANG, Teng-wei WANG, Xiao-ping YU, Kai SUN, Zi-hong YE. 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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Year 2025 volume 45 Issue 2
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Article Info
doi: 10.16155/j.0254-1793.2024-1052
  • Receive Date：2024-08-16
  • Online Date：2026-03-18
  • Published：2025-02-28
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  • Received：2024-08-16
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Affiliations
    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
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