动物布鲁氏菌病活疫苗生产环节生物安全风险分析与对策

Prevention and Control of Biosafety Risk in the Production of Animal Brucellosis Live Vaccine

布鲁氏菌病(布病)活疫苗是世界各国防控布病的重要生物资源,我国目前主要生产和应用的布病活疫苗为S2株、M5株和A19株。生物安全是布病活疫苗生产过程中的必须优先考虑的重要环节,随着兽药GMP(2020年版)的实施,进一步规范布病活疫苗的生产与检验,防控生产环节中的生物安全风险,成为迫切需要研究和解决的突出问题。通过对布病活疫苗生产检验、设施维修维护、生产人员个人防护等环节的生物安全风险点进行分析,对布病活疫苗生产线提出改进建议,为相关企业动物布病活疫苗生产提供参考。

Brucellosis live vaccine is an important biological resource for the prevention and control of brucellosis in the world.At present,the main production and application of brucellosis live vaccine are S2 strain,M5 strain and A19 strain in China.Biosafety is an important priority in the production of live brucellosis vaccine.With the implementation of veterinary drug GMP(2020 version),it is urgent to standardize the production and inspection of brucellosis live vaccine,and prevent and control the biosafety risk in the production process.In order to put forward reasonable and standardized suggestions for the process improvement of brucellosis live vaccine,and provide reference for the production of animal brucellosis vaccine,the possible biosafety risk points in the production and inspection of brucellosis live vaccine,facility maintenance,production personnel protection and other links were analyzed.