Quality by Design-driven systematic development and lifecycle control strategies for polysaccharide conjugate vaccines
10.13200/j.cnki.cjb.004540
- VernacularTitle:质量源于设计理念下多糖结合疫苗系统开发及全过程控制策略
- Author:
YANG Dan
- Publication Type:Journal Article
- Keywords:
Polysaccharide conjugate vaccines;
Quality by Design(QbD);
Process development;
Quality control strategy;
Regulatory science
- From:
Chinese Journal of Biologicals
2025;38(08):1012-1018+1024
- CountryChina
- Language:Chinese
-
Abstract:
The quality of polysaccharide conjugate vaccines is critically dependent on scientific design during early development and lifecycle control. Guided by the Quality by Design(QbD) framework, a systematic development strategy was established, encompassing strain-driven upstream/downstream process development, polysaccharide structure-oriented conjugation process design, carrier protein compatibility optimization, and clinical demand-driven iterative process refinement. By dynamically aligning critical quality attributes(CQAs) with critical process parameters(CPPs), process robustness was ensured. To address complex challenges such as molecular heterogeneity, multi-valent formulation, and batch variability,tailored quality control strategies were proposed based on product characteristics. These encompassed core issues such as functional group-specific control, polysaccharide integrity verification, carrier protein purity assurance, mitigation of crossinterference in multi-valent vaccines, and method selection and cross-validation. Furthermore, the process analytical technology(PAT) and continuous process verification(CPV) were integrated to construct a lifecycle control network spanning early development to commercialization, thereby advancing the alignment of polysaccharide conjugate vaccines with international standards. From a regulatory science perspective, this article systematically elucidates the pivotal role of QbD in safeguarding vaccine quality and clinical efficacy, providing scientific guidance for the rational development, quality enhancement, and lifecycle management of polysaccharide conjugate vaccines.
