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Development of a thermal stabilizer formulation optimized by response surface methodology for Senecavirus A antigen
Zhenru Hu1, Jiankun Huang1, Simiao Zhao1
1School of Tropical Agriculture and Forestry, Hainan University, 570228, Haikou, China.
Journal of Pharmaceutical Sciences
|December 6, 2024
Summary
This study developed a thermal stabilizer to improve Senecavirus A (SVA) vaccine stability. The novel formulation enhances viral infectivity preservation, crucial for storage and transport without a cold chain.
Area of Science:
- Virology
- Biotechnology
- Vaccine Development
Background:
- Picornaviridae viruses, including Senecavirus A (SVA) and foot-and-mouth disease virus (FMDV), are thermally unstable, leading to viral particle dissociation and reduced vaccine potency.
- Maintaining viral infectivity under varying temperatures is critical for vaccine efficacy, especially in settings lacking a consistent cold chain.
Purpose of the Study:
- To develop and optimize a thermal stabilizer formulation to enhance the thermal stability of Senecavirus A (SVA).
- To assess the impact of various excipients on SVA infectivity and identify optimal stabilization conditions.
Main Methods:
- Screening of various excipients (e.g., sucrose, sorbitol, L-arginine) for their ability to retain SVA infectivity.
- Optimization of thermal stabilizer formulations using Box-Behnken experimental design (BBD) and response surface methodology (RSM).
- Evaluation of SVA viral infectivity titers under different temperature conditions (4°C, 25°C, 37°C, and 42°C) over time.
Main Results:
- Several excipients, including sucrose, sorbitol, and L-arginine, demonstrated the ability to retain SVA infectivity.
- Optimized formulations containing sucrose (9.9%), sorbitol (9.9%), and L-arginine (0.06 mol/L) significantly improved SVA thermal stability.
- The stabilized SVA formulation showed minimal viral titer reduction even after 7 days of incubation at 42°C (decrease of 10^1.21 TCID50/mL).
Conclusions:
- A combinational thermal stabilizer effectively enhances SVA stability, preserving viral infectivity at elevated temperatures.
- This formulation offers a viable solution for SVA vaccine storage and transportation, particularly in resource-limited areas without reliable cold chains.
- The developed thermal stabilizer shows potential for broad application in picornavirus vaccine formulations, improving their shelf-life and accessibility.
