应用质量源于设计提升我国疫苗研发水平的思考  

Thoughts on applying Quality by Design(QbD)to improve research and development level of vaccine in China

作　　者：王一平[1] 李克雷 毛群颖[1] 梁争论[1] WANG Yiping;LI Kelei;MAO Qunying;LIANG Zhenglun(National Institutes for Food and Drug Control,Beijing 102629,China;不详)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]北京民海生物科技有限公司,北京102629

出　　处：《中国生物制品学杂志》2024年第11期1395-1400,1408,共7页Chinese Journal of Biologicals

基　　金：国家科技重大专项(2018ZX09101-001);中国医学科学院医学与健康科技创新工程项目(2021-I2M-5-005);中国食品药品检定研究院关键技术基金(GJJS-2022-1-1);药品监管科学全国重点实验室课题(2024SKLDRS0214)。

摘　　要：目前,药品质量管理模式已从“检验控制质量”和“生产控制质量”模式发展为“设计控制质量”模式,强调风险评估、过程控制及持续监测和改进在生产过程中的应用。质量源于设计(Quality by Design,QbD)的理念在治疗性单克隆抗体领域应用较多,但在其他生物制品,特别是疫苗类产品中应用较少,这与疫苗结构复杂、工艺较为传统及质控方法变异度较大等因素有关。加快QbD理念和框架在我国疫苗行业的实施,对提升我国疫苗特别是新型疫苗的质量、安全性和有效性具有重要意义。本文对QbD在疫苗研发中的应用进展作一综述,并分析存在的问题和挑战,以期推动QbD理念在疫苗行业的应用,为进一步提升我国疫苗研发和质控水平提供参考。At present,the mode of Drug Quality Management has developed from the mode of“Quality by Test”and“Quality by Manufacture”to the mode of“Quality by Design”,emphasizing the application of risk assessment,process control,continuous monitoring and improvement in the production process.The concept of“Quality by Design(QbD)”has been widely used in the field of therapeutic monoclonal antibodies,but less in other biological products,especially in vaccines,which is due to the complex structure of vaccine,traditional technologies and the large variability of quality control methods.It is of great significance to speed up the implementation of the concept and framework of QbD for improving the quality,safety and efficacy of vaccines,especially new vaccines in China.In this paper,the application progress of QbD in vaccine research and development has been reviewed,and the existing problems and challenges have been analyzed,so as to provide a reference for promoting the application of QbD concept in vaccine industry and further improving the level of vaccine development and quality control in China.

关 键 词：质量源于设计 分析方法质量源于设计 过程分析技术 疫苗 

分 类 号：R97[医药卫生—药品]