Particle size and size distribution of mRNA vaccines under different testing conditions
10.3760/cma.j.cn112309-20220411-00104
- VernacularTitle:不同检测条件下mRNA疫苗的粒径和粒径分布研究
- Author:
Jingjing LIU
1
;
Miao LI
;
Yuhua LI
Author Information
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
- Keywords:
Particle size;
Size distribution;
mRNA vaccine;
Dynamic light scattering
- From:
Chinese Journal of Microbiology and Immunology
2022;42(11):875-879
- CountryChina
- Language:Chinese
-
Abstract:
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.
