Status and strategic considerations for in vivo potency testing for vaccines in China: toward 3R principles
10.13200/j.cnki.cjb.004562
- VernacularTitle:中国疫苗体内效力检测方法现状和替代、减少、优化方法设计的思考
- Author:
WU Xing
- Publication Type:Journal Article
- Keywords:
Vaccines;
Potency test;
3R principles;
Test in vivo;
Test in vitro;
Quality control;
Consistency testing
- From:
Chinese Journal of Biologicals
2025;38(09):1137-1144+1152
- CountryChina
- Language:Chinese
-
Abstract:
Potency is a critical quality control indicator for vaccines. The promotion of the 3R principles(Replacement,Reduction, Refinement) in animal testing, the full implementation of Good Manufacturing Practice(GMP)/Good Clinical Practice(GCP), the advancement of science-based regulatory frameworks, and the breakthroughs in emerging testing technologies have laid the foundation for developing high-sensitivity in vivo potency optimization strategies or animal-free alternative methods. This article systematically reviews the current status of in vivo potency testing practices for preventive vaccines in China, summarizes the design and quality control requirements of diverse testing protocols, aiming to enhance the scientific rigor of potency testing methodologies, promote animal use reduction and facilitate the adoption of in vitro alternatives, thereby advancing vaccine quality control standards.
