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

文献类型： 外文期刊

作者： Lyu, Fang 1 ; Zhao, Yan-hong 1 ; Zuo, Xiao-xin 1 ; Nyide, Babalwa 2 ; Deng, Bi-hua 1 ; Zhou, Ming-xu 1 ; Hou, Jibo 1 ; Jiao, Jia-jie 1 ; Zeng, Min-qian 1 ; Jie, Hong-ying 1 ; Olaniran, Ademola 3 ; Lu, Yu 1 ; Khoza, Thandeka 2 ;

作者机构： 1.Jiangsu Acad Agr Sci, Natl Res Ctr Engn & Technol Vet Biol, Inst Vet Immunol & Engn, Nanjing 210014, Peoples R China

2.Univ KwaZulu Natal, Coll Agr Engn & Sci, Sch Life Sci, Dept Biochem, ZA-3209 Pietermaritzburg, South Africa

3.Univ KwaZulu Natal, Coll Agr, Sch Life Sci Engn & Sci, Dept Microbiol, ZA-4000 Durban, South Africa

4.GuoTai Taizhou Ctr Technol Innovat Vet Biol, Taizhou 225300, Peoples R China

5.Nanjing Agr Univ, Sch Anim Med, Nanjing 210095, Jiangsu, Peoples R China

6.Minist Sci & Technol, Jiangsu Key Lab Food Qual & Safety, State Key Lab Cultivat Base, Nanjing 210014, Peoples R China

7.Jiangsu Univ, Sch Pharm, Zhenjiang 212013, Peoples R China

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

页码：

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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