Inactivated Enterovirus 71 Particle Aggregation Stability: Dynamic Light Scattering Analysis and Stabilizer Identification.

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.