Freeze-drying Design and Process Amplification of the New Formulation of Swine Fever Vaccine

doi:10.13304/j.nykjdb.2019.0105

Journal of Agricultural Science and Technology ›› 2019, Vol. 21 ›› Issue (12): 110-118.DOI: 10.13304/j.nykjdb.2019.0105

Freeze-drying Design and Process Amplification of the New Formulation of Swine Fever Vaccine

ZUO Xiaoxin1,2, ZHAO Yanhong1,2, DENG Bihua1,2, HU Laigen1,2,3, SONG Wei1,2, LYU Fang1,2,4*, LU Yu1,2,4,5,6, HOU Jibo1,2,4,5

1.Institute of Veterinary Immunology & Engineering, Jiangsu Academy of Agricultural Sciences, Nanjing 210014, China;
2.National Research Center of Engineering and Technology for Veterinary Biologicals, Jiangsu Academy of Agricultural Sciences, Nanjing 210014, China; 3.Chengdu Tecbond Biological Products Co., Ltd., Chengdu 610100, China; 4.Jiangsu Co-Innovation Center for the Prevention and Control of Important Animal Infectious Disease and Zoonose, Yangzhou University, Jiangsu Yangzhou 225009, China; 5.Jiangsu Key Laboratory for Food Quality and Safety-State Key Laboratory Cultivation Base, Ministry of Science and Technology, Jiangsu Yangzhou 225009, China; 6.School of Pharmacy, Jiangsu University, Jiangsu Zhenjiang 212013, China

Received:2019-02-20 Online:2019-12-15 Published:2019-03-28

新型猪瘟耐热活疫苗冻干工艺设计及放大研究

左晓昕1,2,赵艳红1,2,邓碧华1,2,胡来根1,2,3,宋伟1,2,吕芳1,2,4*,卢宇1,2,4,5,6,侯继波1,2,4,5

1.江苏省农业科学院动物免疫工程研究所, 南京 210014; 2.江苏省农业科学院国家兽用生物制品工程技术研究中心, 南京 210014; 3.成都天邦生物制品有限公司, 成都 610100; 4.江苏省动物重要疫病与人兽共患病防控协同创新中心, 江苏扬州 225009; 5.江苏省食品质量安全重点实验室-省部共建国家重点实验室培育基地, 江苏扬州 225009; 6.江苏大学药学院, 江苏镇江 212013

通讯作者: *通信作者吕芳 E-mail：lvfang31@163.com
作者简介:左晓昕 E-mail：15371337073@163.com;
基金资助:
国家重点研发计划项目（2017YFD0500706-2）；江苏省农业科学院探索性颠覆性创新计划项目（ZX\[17\]2016）。

Abstract

Abstract: To screen the thermostable and safe freeze-drying procedure of swine fever vaccine, the magnification of lyophilization was explored to provide theoretical basis and technical support for heat-resistant freeze-drying process from laboratory to production. The freeze-drying procedures were designed based on the thermal parameters, and screened through the freezing shape, accelerated aging experiment, residual water and other indicators. The results showed that the eutectic point of the new swine fever-resistant live vaccine solution was -26.4 ℃, the collapse temperature -22.4 to -20.4 ℃, and the freeze-drying procedure 3 was screened as the optimal curve when the prefreeze temperature was -42 ℃ and the main drying temperature was -10 ℃. This study successfully screened the optimal freeze-drying process 3 was adequate for 0.5 m2 freeze-dryer, and the temperatures of pre-freezing and primary drying were -42 ℃ and -10 ℃, respectively. The procedure 3 in 0.15 m2—0.5 m2—2 m2 enlarged the process of the process groping, scaled up 3 times (0.5 m2) when the program could remain unchanged, zoomed in to 13 times (2 m2) under the main drying phase which needed reducing the partition temperature and extending the drying time. Frozen live vaccine products prepared with a new swine fever-resistant formula and program 3 could be saved at 37 ℃ for 20 d, 45 ℃ for 14 d, and animal experiments were safe. These results showed that the freeze-drying process of the new heat-resistant formulation was successfully screened out, and the process was enlarged step by step.

Key words: classical swine fever virus, freeze drying, process magnification, heat resistance, security

摘要： 为了筛选耐热、安全的猪瘟活疫苗冻干工艺，探索工艺放大规律，为耐热冻干工艺从实验室到生产提供理论依据和技术支撑。根据新型猪瘟耐热配方的热参数科学设计冻干程序，通过冻形、加速耐老化实验、残余水分等指标筛选冻干程序并进行工艺放大。结果表明，新型猪瘟耐热活疫苗溶液的共晶点为-26.4 ℃、塌陷温度-22.4～-20.4 ℃，筛选得到冻干程序3，当预冻温度为-42 ℃，主干燥温度为-10 ℃时为最优曲线。将程序3在0.15 m2—0.5 m2—2 m2进行逐级工艺放大摸索，规模放大3倍（0.5 m2）时程序可不变，放大到13倍（2 m2）时需在主干燥阶段下调隔板温度、延长干燥时间。采用新型猪瘟耐热配方及程序3制备的冻干活疫苗产品可在37 ℃保存20 d、45 ℃保存14 d；动物实验安全。上述结果表明成功筛选出新型猪瘟耐热配方的配套冻干工艺，并实现了工艺的逐级放大。

关键词: 猪瘟, 冷冻干燥, 工艺放大, 耐热性能, 安全性

ZUO Xiaoxin1,2, ZHAO Yanhong1,2, DENG Bihua1,2, HU Laigen1,2,3, SONG Wei1,2, LYU Fang1,2,4*, LU Yu1,2,4,5,6, HOU Jibo1,2,4,5. Freeze-drying Design and Process Amplification of the New Formulation of Swine Fever Vaccine[J]. Journal of Agricultural Science and Technology, 2019, 21(12): 110-118.

左晓昕1,2,赵艳红1,2,邓碧华1,2,胡来根1,2,3,宋伟1,2,吕芳1,2,4*,卢宇1,2,4,5,6,侯继波1,2,4,5. 新型猪瘟耐热活疫苗冻干工艺设计及放大研究[J]. 中国农业科技导报, 2019, 21(12): 110-118.

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Freeze-drying Design and Process Amplification of the New Formulation of Swine Fever Vaccine

新型猪瘟耐热活疫苗冻干工艺设计及放大研究

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