mRNA疫苗纳米递送系统研究进展及监管考量

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

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,包括聚合物运载技术、脂质运载技术、脂质纳米粒技术、脂质-聚合物复合物技术等方面进行详细论述。各递送系统通过巧妙的设计,优化提高了细胞转染率及机体免疫应答,使mRNA疫苗在临床预防/治疗方面的作用充分发挥。同时,纳米递送系统的作用机制、安全性、有效性及质量可控性等方面仍需进一步研究明确,更好地满足人民群众临床用药需求。

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.