mRNA疫苗纳米递送系统研究进展及监管考量

目的:汇总分析国内外信使核糖核酸(mRNA)疫苗纳米递送系统的研究进展及关键技术,为mRNA疫苗产品开发、质量控制及上市后监管提供参考.方法:通过文献调研,对已上市产品/临床试验阶段产品进行分析,并参考国内外指导原则,梳理目前研究较多的mRNA疫苗纳米递送系统的特点及质量控制要点.结果 与结论:对纳米递送平台,包括聚合...

A Review on Nano-Delivery System for mRNA Vaccine and its Regulatory Consideration

Objective: The research process and the critical technique of the nano-delivery system of mRNA vaccine at home and abroad were summarized and analyzed to provide references for development, quality control and post marketing supervision of mRNA vaccine products. Methods: Based on the literature research, the products on the market or in the clinical trial stage were analyzed, the characteristics and quality control points of nano-delivery system of mRNA vaccine that is currently studied were summarized by referring to the guiding principles at home and abroad. Results and Conclusion: The nano-delivery platforms, including polyplexes (PPs), lipoplexes (PLX), lipid nanoparticles (LNP) and lipopolyplexs (LPP), etc., were discussed in detail. By the means of ingenious design, the delivery system improves the rate of cell transfection and the immune response of the body, which makes mRNA vaccine play a full function in clinical prevention and treatment. Meanwhile, the mechanism of action, the safety, effectiveness and quality control of the nano-delivery system still need to be further studied to better meet the clinical drug needs of the public.