动物mRNA疫苗生产厂房布局与工艺设计要点探究  

A Study on Plant Layout and Process Design of Animal mRNA Vaccine Manufacturing Facility

作　　者：刘业兵[1] 吴涛[1] 夏应菊 陈紫昱 李佳昕 张存帅[1] LIU Ye-bing;WU Tao;XIA Ying-ju;CHEN Zi-yu;LI Jia-xin;ZHANG Cun-shuai(National Reference Laboratory for Classical Swine Fever,China Institute of Veterinary Drug Control,Beijing 100081,China)

机构地区：[1]中国兽医药品监察所(农业农村部兽药评审中心)国家猪瘟参考实验室,北京100081

出　　处：《中国兽药杂志》2024年第2期71-80,共10页Chinese Journal of Veterinary Drug

基　　金：国家重点研发计划“猪瘟mRNA疫苗新型脂质体纳米佐剂产品创制及免疫评价”(2023YFD1802604-5)。

摘　　要：mRNA疫苗技术具备研发周期短、安全性优良、生产技术通用性强的特点,但由于mRNA疫苗的特殊工艺,传统的生物制品厂房设计已不能完全满足其制备要求。科学合理的厂房工艺设计是确保mRNA疫苗产能与质量的主要条件,因此,如何设计既符合工艺要求又满足兽药GMP的动物mRNA疫苗生产厂房成为摆在我们面前急需探究的课题。鉴于不同国家在能源结构、环保要求、设计理念等方面存在差异,在借鉴欧美已有的mRNA疫苗规模化生产设施和我国人用mRNA疫苗厂房设计的基础上,提出了符合我国兽药GMP规范的mRNA疫苗厂房生产设施、工艺关键点和设计方案,以期为国内动物mRNA疫苗车间建设提供参考。mRNA vaccine technology is characterized by short development cycles,excellent safety,and strong production technology universality.However,due to the special process of mRNA vaccines,the traditional design concepts of biopharmaceutical production facilities cannot fully meet the requirements for their preparation.The scientific and rational design of production facilities is the main condition to the quality and yield of vaccines.Therefore,how to design the production plant that meets the both process requirements and GMP has become an urgent problem for us to explore.Given the differences in energy structure,environmental protection requirements and design concepts among different countries,based on the scale-up mRNA vaccine production facilities in Europe and the United States and the design of human mRNA vaccine workshops,we proposed the production facilities,process key points and design scheme that comply with the GMP regulations for veterinary drugs in China.This is done in hopes of providing a reference for the domestic industrialization of animal mRNA vaccines plant.

关 键 词：动物 mRNA疫苗 生产设施 工艺设计 GMP 

分 类 号：S851.66[农业科学—预防兽医学]