生物技术药物是所有以生物质为原料的生物活性物质及其人工合成类似物通过现代生物技术制得的药物，包括细胞因子、重组蛋白、抗体、疫苗和寡核苷酸等，临床上已开始广泛应用，为制药工业带来了革命性变化。但是生物技术药物中残留DNA可能存在安全性问题，因此应尽可能将产品中残留DNA的水平降到最低。新版美国药典将推荐实时定量PCR法作为生物技术药物中宿主残留DNA检定的唯一标准方法。该法的技术优势在于序列特异性高、灵敏度高、重现性好，还可以实现定量检测，使得结果更为精确，从而为生物技术药物企业在工艺研究和成品质量控制方面提供了可靠的检测手段。此综述对4类检测方法进行了比较，重点比较两种实时定量方法。

Biotech drugs are drugs made by modern biotechnology with bioactive substances and their synthetic analogs, using biomass as raw materials. Biotech drugs, including cytokines, recombinant proteins, antibodies, vaccines, and oligonucleotides, have begun to be widely used clinically, and brought revolutionary change for the pharmaceutical industry. However, residual DNA in biological products may be potentially dangerous, so purification processes need to be validated to confirm its clearance. The new United States pharmacopoeia will recommend real-time quantitative PCR method be the only standard method for testing host residual DNA in biotech drugs. This method has the technical advantage of high specificity, high sensitivity, good reproducibility, and quantitative detection, making results more accurate, thereby provides a reliable means of detection in process research and product quality control for biopharmaceutical enterprises. This review compares 4 types of testing methods and focuses on two real-time quantitative methods.