动物源性医疗器械中残留DNA表征和风险的研究进展

动物源性医疗器械可能含有来自宿主细胞的DNA,这些残留DNA可能将其编码的癌基因、感染性成分传递给使用者,从而导致肿瘤或感染的危险。基于风险分析的安全性研究是进行产品质量控制的基础,其中残留DNA表征是动物源性医疗器械进行质量控制的重要措施,对产品的安全性至关重要。本文通过对动物源性材料中残留DNA的表征和潜在的危害及其控制措施等研究进展进行综述,将推动产品工艺优化,使残留DNA风险控制在最低水平,助力动物源性医疗器械研发和生产。

Research Progress On the Characterization and Risk of Residual DNA In Animal-derived Medical Devices

DNA from host cells can be presented in the animal-derived medical devices. There is a possibility for the residual DNA to transmit an activated oncogene or infectious agents to product recipients, and leading to possible oncogenic or infective events as well. The precondition of medical devices quality control is risk analysis-based safety studies, in which characterization of residual DNA is an essential requirement for quality control of animal-derived medical devices and is critical to product safety. The research progress on the characterization, potential hazards and quality control of residual DNA in animal-derived medical devices were systematically summarized and analyzed. It is important to minimize the risk of residual DNA by improving the process optimization, which will promote the research, development and production of animal-derived medical devices.