不同检测条件下mRNA疫苗的粒径和粒径分布研究  

Particle size and size distribution of mRNA vaccines under different testing conditions

作　　者：刘晶晶[1] 李淼 李玉华[1] Liu Jingjing;Li Miao;Li Yuhua(Department of Arbovirus Vaccine,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,NMPA Key Laboratory for Quality Research and Evaluation of Biological Products,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院虫媒病毒疫苗室,国家卫生健康委员会生物技术产品检定方法及标准化重点实验室,国家药品监督管理局生物制品质量研究与评价重点实验室,北京102629

出　　处：《中华微生物学和免疫学杂志》2022年第11期875-879,共5页Chinese Journal of Microbiology and Immunology

基　　金：国家重点研发计划(2020YFC0860500)。

摘　　要：目的探讨可能影响mRNA疫苗粒径和粒径分布的因素。方法在不同离子强度缓冲液、pH值、稀释剂类型、稀释度和检测仪器条件下,采用动态光散射法对3批mRNA疫苗的粒径和粒径分布进行检测。结果稀释剂的离子强度增大时,疫苗的粒径随之增大,粒径分布不发生改变;稀释剂的pH值增加时,疫苗的粒径随之增大,当pH值达到弱碱性时,粒径分布出现明显变化;选择不同溶液作为稀释剂时,mRNA疫苗的粒径均不同,粒径分布无明显变化;疫苗稀释度≤100时,粒径和粒径分布均无明显改变;不同仪器参数下疫苗的粒径和粒径分布差异无统计学意义,但粒径分布略有不同。结论粒径和粒径分布受稀释剂、稀释度和检测仪器等因素影响,在生产与质控中应予以关注。Objective To investigate the factors that could influence the particle size and size distribution of mRNA vaccines.Methods The influences of several factors including the ionic strength and pH values of buffers,solutions,dilution folds and testing equipments on the particle size and size distribution of three batches of mRNA vaccines were analyzed by dynamic light scattering.Results The particle size increased with increasing ionic strength,but no significant change in size distribution was observed.The particle size also increased with increasing pH values and the size distribution showed significant change when the buffer solution was weakly alkaline.Solution types could affect the particle size,but had no influence on size distribution.There was no significant change in the particle size or size distribution when the dilution was limited to 100 folds.Moreover,the particle size and size distribution detected by different equipments showed no significance difference.Conclusions The particle size and size distribution of mRNA vaccines could be affected by solution,dilution fold and testing equipment,which should be concerned during the vaccine production and quality control.

关 键 词：粒径 粒径分布 mRNA疫苗 动态光散射 

分 类 号：R392-33[医药卫生—免疫学]