Thoughts on applying Quality by Design(QbD) to improve research and development level of vaccine in China

VernacularTitle:应用质量源于设计提升我国疫苗研发水平的思考
Author: WANG Yiping
Publication Type:Journal Article
Keywords: Quality by Design(QbD); Analytical Quality by Design(AQbD); Process Analytical Technologies(PATs); Vaccine
From: Chinese Journal of Biologicals 2024;37(11):1395-1400+1408
CountryChina
Language:Chinese
Abstract: At present, the mode of Drug Quality Management has developed from the mode of“Quality by Test”and“Quality by Manufacture”to the mode of“Quality by Design”, emphasizing the application of risk assessment, process control, continuous monitoring and improvement in the production process. The concept of“Quality by Design(QbD)”has been widely used in the field of therapeutic monoclonal antibodies, but less in other biological products, especially in vaccines, which is due to the complex structure of vaccine, traditional technologies and the large variability of quality control methods. It is of great significance to speed up the implementation of the concept and framework of QbD for improving the quality, safety and efficacy of vaccines, especially new vaccines in China. In this paper, the application progress of QbD in vaccine research and development has been reviewed, and the existing problems and challenges have been analyzed, so as to provide a reference for promoting the application of QbD concept in vaccine industry and further improving the level of vaccine development and quality control in China.