Particle size and size distribution of mRNA vaccines under different testing conditions / 中华微生物学和免疫学杂志

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.