中国基于脂质纳米颗粒的mRNA疫苗质量评价的监管视角

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals Pub Date : 2023-09-12 DOI:10.1016/j.biologicals.2023.101700

Jiaqi Lu, Wei Wei, Wu He

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引用次数: 0

摘要

近年来，由于新冠肺炎大流行，医疗需求急需得到满足，这加速了mRNA技术在疫苗开发中的应用，导致世界各地监管机构批准了人类历史上首批mRNA疫苗。对于市场授权，需要全面的化学、制造和控制（CMC）信息，以确保信使核糖核酸疫苗的安全性和质量一致性。评估新病毒变种的信使核糖核酸疫苗对监管机构来说是一个挑战，因为基于先前平台知识的快速优化和开发可以加速开发过程，而传统上这对生物产品来说是有限的。在此，我们根据现有的科学知识总结了目前CMC对mRNA疫苗评估的监管考虑，这些知识将随着mRNA生物学和药物科学的进步而更新。

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Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China

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.

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来源期刊

Biologicals 生物-生化研究方法

CiteScore

3.70

自引率

0.00%

发文量

审稿时长

48 days

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.