基于重组蛋白新冠疫苗生产现场的检查要点分析

Analysis of Inspection Points on the Production Site of Recombinant Protein COVID-19 Vaccine

新冠疫情使人们普遍认识到疫苗对于公共卫生的重要性,重组蛋白疫苗作为重要的疫苗类型,因其保护效力和安全性的优势受到广泛关注。重组蛋白疫苗的生产一般包括种子库的建立和检定、原液生产、制剂生产、质量检验等过程。现场检查中需要重点关注蛋白生物活性的工艺控制,随着重组蛋白疫苗关注度的提升,生产现场检查规范的建立与完善成为一个重要课题。

The COVID-19 pandemic has made people generally realize the importance of vaccines for public health.Recombinant protein vaccines,as an important type of vaccine,have received widespread attention due to their advantages of protective efficacy and safety.The production of recombinant protein vaccines generally includes the establishment and verification of seed banks,production of stock solutions,production of formulations,quality inspection,and other processes.In field inspection,it is necessary to focus on the process control of protein biological activity.With the increasing attention paid to recombinant protein vaccines,the establishment and improvement of production site inspection standards has become an important topic.