Effects of vacuum freeze-drying based on different lyoprotectants on the stability of foot-and-mouth disease virus-like particles.

Wei GUO; Qianqian XIE; Ruipeng LIU; Hu DONG; Yun ZHANG; Xiaoqiang WANG; Shiqi SUN; Huichen GUO; Zhidong TENG

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Effects of vacuum freeze-drying based on different lyoprotectants on the stability of foot-and-mouth disease virus-like particles.

Author: Wei GUO ¹ ; Qianqian XIE ¹ ; Ruipeng LIU ¹ ; Hu DONG ¹ ; Yun ZHANG ¹ ; Xiaoqiang WANG ² ; Shiqi SUN ¹ ; Huichen GUO ¹ ; Zhidong TENG ¹
Author Information

1. State Key Laboratory for Animal Disease Control and Prevention, College of Veterinary Medicine and Biosafety, Lanzhou University, Lanzhou Veterinary Research Institute, Chinese Academy of Agricultural Sciences, Lanzhou 730000, Gansu, China.
2. College of Biological and Pharmaceutical Engineering, Lanzhou Jiaotong University, Lanzhou 730070, Gansu, China.
Publication Type:Journal Article
Keywords: foot-and-mouth disease virus-like particles; immune effects; lyoprotectants; stability; vacuum freeze-drying
MeSH: Freeze Drying/methods*; Animals; Foot-and-Mouth Disease Virus/immunology*; Mice; Vaccines, Virus-Like Particle/chemistry*; Foot-and-Mouth Disease/immunology*; Vacuum; Drug Stability; Mice, Inbred BALB C; Viral Vaccines/immunology*
From: Chinese Journal of Biotechnology 2025;41(7):2682-2693
CountryChina
Language:Chinese
Abstract: Vaccination is a crucial strategy for the prevention and control of infectious diseases. Virus-like particles (VLPs), composed of structural proteins, have garnered significant attention as a novel type of vaccine due to their excellent safety and immunogenicity. However, similar to most vaccine antigens, VLPs exhibit insufficient thermal stability, which not only restricts the widespread application of vaccines but also increases the risk of vaccine inactivation. This study aims to enhance the stability and shelf life of VLPs derived from type A foot-and-mouth disease virus (FMDV) by employing vacuum freeze-drying technology. The optimal lyoprotectant formulation was determined through single-factor and combinatorial screening. Subsequently, the correlation between the immunogenicity of the freeze-dried vaccine and the content of FMDV VLPs was evaluated via a mouse model. The stability of FMDV VLPs before and after freeze-drying was further assessed by storing them at 4, 25, and 37 ℃ for varying time periods. Results indicated that the lyoprotectant formulation No.1, composed of 7.5% trehalose, 0.1% Tween 80, 50 mmol/L glycine, 1% sodium glutamate, and 3% polyvinylpyrrolidone (PVP), effectively preserved the content of FMDV VLPs during the vacuum freeze-drying process. The immunization trial in mice revealed that the levels of specific antibodies, immunoglobulin G1 (IgG1), interleukin-4 (IL-4), and neutralizing antibodies induced by freeze-dried FMDV VLPs were comparable to those induced by non-freeze-dried FMDV VLPs. The heat treatment results showed that the storage periods of freeze-dried FMDV VLPs at 4, 25, and 37 ℃ were significantly longer than those of non-freeze-dried FMDV VLPs. In conclusion, the selected lyoprotectant formulation effectively improved the stability of FMDV VLPs vaccines. This study provides valuable insights for enhancing the stability of novel subunit vaccines.