Vaccinology
Particle size and size distribution of mRNA vaccines under different testing conditions
Liu Jingjing, Li Miao, Li Yuhua
Published 2022-11-30
Cite as Chin J Microbiol Immunol, 2022, 42(11): 875-879. DOI: 10.3760/cma.j.cn112309-20220411-00104
Abstract
ObjectiveTo investigate the factors that could influence the particle size and size distribution of mRNA vaccines.
MethodsThe 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.
ResultsThe 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.
ConclusionsThe 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.
Key words:
Particle size; Size distribution; mRNA vaccine; Dynamic light scattering
Contributor Information
Liu Jingjing
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
Li Miao
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
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
