{"title":"Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China","authors":"Jiaqi Lu, Wei Wei, Wu He","doi":"10.1016/j.biologicals.2023.101700","DOIUrl":null,"url":null,"abstract":"<div><p>In recent years, urgent unmet medical needs due to the COVID-19 pandemic have accelerated the application of mRNA technology in vaccine development, leading to some of the first approvals of mRNA vaccines<span> in human history by regulatory agencies around the world. For market authorization, comprehensive chemistry, manufacturing and control (CMC) information is required to assure the safety and quality consistency of mRNA vaccines. Evaluating mRNA vaccines for new virus variants poses a challenge for regulators, given the rapid optimization and development based on prior platform knowledge to accelerate the development process, which is traditionally limited for biological products. Here we summarize the current regulatory considerations of CMC evaluation on mRNA vaccines based on the scientific knowledge available, which will be updated with the advance of mRNA biology and pharmaceutical science.</span></p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"84 ","pages":"Article 101700"},"PeriodicalIF":1.5000,"publicationDate":"2023-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biologicals","FirstCategoryId":"99","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1045105623000386","RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
引用次数: 0
Abstract
In recent years, urgent unmet medical needs due to the COVID-19 pandemic have accelerated the application of mRNA technology in vaccine development, leading to some of the first approvals of mRNA vaccines in human history by regulatory agencies around the world. For market authorization, comprehensive chemistry, manufacturing and control (CMC) information is required to assure the safety and quality consistency of mRNA vaccines. Evaluating mRNA vaccines for new virus variants poses a challenge for regulators, given the rapid optimization and development based on prior platform knowledge to accelerate the development process, which is traditionally limited for biological products. Here we summarize the current regulatory considerations of CMC evaluation on mRNA vaccines based on the scientific knowledge available, which will be updated with the advance of mRNA biology and pharmaceutical science.
期刊介绍：
Biologicals provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine. The journal publishes original papers, reviews, and letters relevant to the development, production, quality control, and standardization of biological derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular international interest and concern.Three types of papers are welcome: original research reports, short papers, and review articles. The journal will also publish comments and letters to the editor, book reviews, meeting reports and information on regulatory issues.
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