生物制品中宿主细胞残留DNA检测的研究进展

宿主细胞残留DNA是指可能出现于生物制品中的来自宿主细胞的DNA片段。用传代细胞株生产的生物制品，其宿主细胞残留DNA可能会传递肿瘤或病毒相关基因，存在潜在的危险性。各国药品监督管理机构对宿主细胞残留DNA的残留量有着严格的限度控制，同时各国药典也提供数种经典的检测方法。建立合适的宿主细胞残留DNA检测方法有助于监测生产工艺，确保生物制品的安全性和质量。此文对宿主细胞残留DNA潜在的危害、国内外监管机构对宿主细胞残留DNA检测标准和检测方法以及各方法的特点及研究进展做一综述。

Research progress on detection of residual host cell DNA in biological products#br#

Host cell residual DNA is DNA fragment from host cells that may exist in biological products. Host cell residual DNA in biological products produced by passage cell lines may carry tumor or virus-related genes and has potential risks. Thus, drug regulatory agencies in various countries have strict limits on host cell DNA residual amounts, and pharmacopoeias of various countries have provided several classic detecting methods. Establishing appropriate methods for detecting residual DNA of host cells can help monitor the production process and ensure the safety and quality of biological products. This article reviews the potential risks of host cell residual DNA, standards and testing methods of host cell residual DNA from domestic and foreign regulatory agencies, and the characteristics of each method and its research progress.