真空冷冻干燥技术在疫苗研发与生产中的应用

Application of Vacuum Freeze-drying Technology in the Development and Production of Vaccine

目前,世界各国都在积极应对新冠肺炎(COVID-19)疫情所带来的影响。新冠疫苗的研发与生产,已成为各国科研院所和医疗企业关注的焦点。同液体疫苗相比,冻干疫苗的运输和储存较容易,为解决疫苗冷链运输难题提供了一种可行方案。真空冷冻干燥技术作为冻干疫苗生产中的关键一环,对疫苗的安全性和有效性起着至关重要的作用。本文首先介绍了冷冻干燥的基本原理和冻干机的主要结构,随后阐述了疫苗的冻干工艺及冻干疫苗的优缺点,并进一步讨论了影响冻干疫苗质量的主要因素(包括保护剂的选择和冻干参数的设计)。作者希望本文所述内容,能为新冠肺炎疫苗的研发与生产提供些许帮助。

Currently,countries around the world are actively responding to the impact of the COVID-19 epidemic.The development and production of COVID-19 vaccines have become the focus of research institutes and medical enterprises.Compared with liquid vaccines,lyophilized vaccines can be transported and stored easily,which provides a feasible solution to solve the problem of cold chain transportation of vaccines.Vacuum freeze-drying technology is a key link in the production of lyophilized vaccines,which plays a vital role in the safety and efficacy of vaccines.In this paper,the basic principle of freezedrying and the main structure of the freeze dryer are introduced firstly.Then,the freeze-drying process of vaccine and the advantages and disadvantages of freeze-drying vaccine are described.Furthermore,the main factors affecting the quality of freezedrying vaccine(including the selection of protective agent and the design of freeze-drying parameters)are also discussed.The authors hope that this article may contribute to the development and production of COVID-19 vaccines.