摘要
mRNA新冠疫苗的成功开发和应用,充分阐明了mRNA技术在生物医药领域的巨大潜力和应用前景。目前,全球范围内有许多公司正在研发基于mRNA技术的药物和疫苗,用于预防和治疗各种疾病。可以预见,随着mRNA药物的不断上市,与之匹配的商业化GMP生产能力,亦迫在眉睫;且生产工艺的优化、智能制造等风险管控策略,以及产业化成本的控制,将有助于提高mRNA创新药物开发的核心竞争力。鉴于此,本文将概述全球mRNA药物的生产工艺和相关GMP生产动态的进展,梳理mRNA产业链的关键链点,探讨mRNA药企价值链的构建和核心竞争力的形成,为我国mRNA创新药物研发及高质量发展提供借鉴和参考。
The successful development and application of mRNA COVID-19 vaccine fully illustrated the great potential and application prospect of mRNA technology in the field of biomedicine.Currently,many companies worldwide are developing drugs and vaccines based on mRNA technology for the prevention and treatment of various diseases.It can be foreseen that with the continuous launch of mRNA drugs,commercial GMP production capacity matching them is also urgent.The optimization of production processes,intelligent manufacturing and other risk control strategies,as well as the control of industrialization costs,will help improve the core competitiveness of mRNA innovative drug development.In view of this,this article will provide an overview of the global production process of mRNA drugs and the progress of related GMP production dynamics,sort out the key chain points of the mRNA industry chain,explore the construction of the mRNA pharmaceutical enterprise value chain and the formation of core competitiveness,and provide reference and reference for the research and development of innovative mRNA drugs and high-quality development in China.
作者
赵长春
黄海
辜勇军
王登刚
宋相容
ZHAO Chang-chun;HUANG Hai;GU Yong-jun;WANG Deng-gang;SONG Xiang-rong(Chengdu WestGene Biopharma Co.,Ltd.,Chengdu 610218,China;State Key Laboratory of Biotherapy,West China Hospital,Sichuan University,Chengdu 610041,China)
出处
《药学学报》
CAS
CSCD
北大核心
2023年第8期2353-2363,共11页
Acta Pharmaceutica Sinica
基金
四川省重大科技专项项目(2022ZDZX0024).