摘要
mRNA疫苗在碱基修饰和脂质递送系统等创新技术的不断驱动下,因研发快、生产周期短、无需大规模细胞和病毒培养等特点而广受关注,在应对COVID-19疫情方面发挥了重要作用,成为了新发突发传染病防控的重要技术路线。目前,mRNA技术产品已在传染性疾病的预防、自身免疫疾病、罕见病以及癌症治疗等多个方向证明了其功效和优势。本文综述了预防用mRNA疫苗原液和制剂的生产工艺,重点讨论了mRNA疫苗全生产过程中的质量控制要点,以及全生命周期质量控制理念,强调了mRNA疫苗质量的重要性,为预防用mRNA产品发展提供科学技术参考。
Over the past few decades,mRNA vaccines have evolved rapidly,especially in terms of modified nucleotides and lipid delivery systems,and attracted widespread attention due to its fast development,short production cycle,and no need for large-scale cell or virus cultivation.This technology has played a crucial role in the prevention and control of COVID-19 pandemic,and become an important technical route for the prevention and control of emerging infectious diseases.Currently,mRNA technology-based products have proven their efficacy and advantages in the prevention of infectious diseases and the treatment of autoimmune diseases,rare diseases,and cancer.In this review,we summarize the production technologies for preparing both stock solutions and preventive mRNA vaccines,discuss the key points in quality control during the whole production process and the concept of quality lifecycle management,and emphasize the importance of quality control,hoping to provide scientific and technical reference for the development of preventive mRNA products.
作者
刘晶晶
李玉华
Liu Jingjing;Li Yuhua(Department of Arbovirus Vaccine,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,NMPA Key Laboratory for Quality Research and Evaluation of Biological Products,National Institute for Food and Drug Control,Beijing 102629,China)
出处
《中华微生物学和免疫学杂志》
CAS
CSCD
北大核心
2024年第10期912-916,共5页
Chinese Journal of Microbiology and Immunology
关键词
mRNA疫苗
传染性疾病
生产工艺
质量控制
mRNA vaccines
Infectious diseases
Production technology
Quality control
