Vaccines · 2025
Inactivated Enterovirus 71 Particle Aggregation Stability: Dynamic Light Scattering Analysis and Stabilizer Identification.
СтатьяНазвание и аннотация: Перевод в очереди
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Yang Anna, Yang Dongsheng, Pang Deqin, Yang Jie, Wang Wenhui, Du Yaxin, Wan Xin, Meng Shengli, Guo Jing, Shen Shuo
Аннотация
BACKGROUND: Inactivated enterovirus 71 (EV71) vaccines play a vital role in preventing severe cases of hand, foot, and mouth disease, with their quality and stability determined by the degree of viral particle aggregation.
OBJECTIVE: This study aimed to use dynamic light scattering (DLS) for monitoring EV71 particle size, comprehensively evaluate the effects of environmental stresses on viral aggregation, and identify suitable stabilizing agents.
METHODS: The DLS technique was validated. Using this method, the effects of pH, ionic strength, freeze-thaw cycles, temperature, and mechanical stresses on viral particle size were assessed. Additionally, the ability of different buffer salts and stabilizers to inhibit stress-induced aggregation was systematically evaluated.
RESULTS: The DLS method exhibited robust performance. EV71 particles were stable at pH 7.0-7.5. Exposure to 47 °C and magnetic stirring promoted viral aggregation. Phosphate buffer and citrate buffer exhibited the highest inhibitory effects on heat-induced aggregation and stirring-induced aggregation, respectively. M199 and Tween 80 efficiently mitigated heat-induced particle aggregation and shear stress-induced particle aggregation, respectively.
CONCLUSIONS: This study demonstrated the performance of DLS in viral aggregation monitoring. Additionally, this study revealed tailored stabilization strategies, providing key insights for vaccine formulation and quality control.
OBJECTIVE: This study aimed to use dynamic light scattering (DLS) for monitoring EV71 particle size, comprehensively evaluate the effects of environmental stresses on viral aggregation, and identify suitable stabilizing agents.
METHODS: The DLS technique was validated. Using this method, the effects of pH, ionic strength, freeze-thaw cycles, temperature, and mechanical stresses on viral particle size were assessed. Additionally, the ability of different buffer salts and stabilizers to inhibit stress-induced aggregation was systematically evaluated.
RESULTS: The DLS method exhibited robust performance. EV71 particles were stable at pH 7.0-7.5. Exposure to 47 °C and magnetic stirring promoted viral aggregation. Phosphate buffer and citrate buffer exhibited the highest inhibitory effects on heat-induced aggregation and stirring-induced aggregation, respectively. M199 and Tween 80 efficiently mitigated heat-induced particle aggregation and shear stress-induced particle aggregation, respectively.
CONCLUSIONS: This study demonstrated the performance of DLS in viral aggregation monitoring. Additionally, this study revealed tailored stabilization strategies, providing key insights for vaccine formulation and quality control.