Thermostable vacuum foam dried Newcastle disease vaccine: Process optimization and pilot-scale study

文献类型： 外文期刊

第一作者： Lyu, Fang

作者： Lyu, Fang;Zhao, Yan-hong;Zuo, Xiao-xin;Deng, Bi-hua;Zhou, Ming-xu;Hou, Jibo;Jiao, Jia-jie;Zeng, Min-qian;Jie, Hong-ying;Lu, Yu;Lyu, Fang;Nyide, Babalwa;Khoza, Thandeka;Olaniran, Ademola;Lyu, Fang;Deng, Bi-hua;Zhou, Ming-xu;Lu, Yu;Lyu, Fang;Zhao, Yan-hong;Deng, Bi-hua;Jiao, Jia-jie;Zeng, Min-qian;Lu, Yu;Zuo, Xiao-xin;Lu, Yu

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关键词： Vacuum foam drying; Process upscaling; NDV vaccine; Thermostability

期刊名称：APPLIED MICROBIOLOGY AND BIOTECHNOLOGY （ 影响因子：3.9； 五年影响因子：4.9 ）

ISSN： 0175-7598

年卷期： 2024 年 108 卷 1 期

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收录情况： SCI

摘要： Vacuum foam drying (VFD) has been shown to improve the thermostability and long-term shelf life of Newcastle Disease Virus (NDV). This study optimized the VFD process to improve the shelf life of NDV at laboratory-scale and then tested the optimized conditions at pilot-scale. The optimal NDV to T5 formulation ratio was determined to be 1:1 or 3:2. Using the 1:1 virus to formulation ratio, the optimal filling volumes were determined to be 13-17% of the vial capacity. The optimized VFD process conditions were determined to be at a shelf temperature of 25 degrees C with a minimum overall drying time of 44 h. The vaccine samples prepared using these optimized conditions at laboratory-scale exhibited virus titer losses of <= 1.0 log(10) with residual moisture content (RMC) below 3%. Furthermore, these samples were transported for 97 days around China at ambient temperature without significant titer loss, thus demonstrating the thermostability of the NDV-VFD vaccine. Pilot-scale testing of the NDV-VFD vaccine at optimized conditions showed promising results for up-scaling the process as the RMC was below 3%. However, the virus titer loss was slightly above 1.0 log10 (approximately 1.1 log(10)). Therefore, the NDV-VFD process requires further optimization at pilot scale to obtain a titer loss of <= 1.0 log(10). Results from this study provide important guidance for possible industrialization of NDV-VFD vaccine in the future. Key points The process optimization and scale-up test of thermostable NDV vaccine prepared through VFD is reported for the first time in this study. The live attenuated NDV-VFD vaccine maintained thermostability for 97 days during long distance transportation in summer without cold chain conditions. The optimized NDV-VFD vaccine preparations evaluated at pilot-scale maintained acceptable levels of infectivity after preservation at 37degree celsius for 90 days, which demonstrated the feasibility of the vaccine for industrialization.

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