Interpretation and consideration of “Substitution of in vivo method(s) by in vitro method(s) for the quality control of vaccines” in General Texts of European Pharmacopoeia
10.13200/j.cnki.cjb.003784
- VernacularTitle:《欧洲药典》通则“用于疫苗质量控制的体外方法替代体内方法”的解读和思考
- Author:
Xuan-xuan ZHANG
1
;
Xing WU
1
;
Qun-ying MAO
1
;
Miao XU
1
;
Zheng-lun LIANG
1
Author Information
1. Institute of Biological Products,National Institutes for Food and Drug Control
- Publication Type:Guideline
- Keywords:
Vaccine;
Quality control;
Potency;
In vivo potency;
In vitro potency;
Method substitution
- From:
Chinese Journal of Biologicals
2023;36(1):1-4+10
- CountryChina
- Language:Chinese
-
Abstract:
Interpretation and consideration of “Substitution of in vivo method(s) by in vitro method(s) for the quality control of vaccines” in General Texts of European Pharmacopoeia:Potency is a critical quality attribute for controlling relevant biological properties and batch consistency of vaccines.The methods can be divided into in vivo and in vitro methods according to whether animals are used.The in vivo methods are large consuming of animals and time,as well as have large variant detection results.In contrast,the in vitro alternative methods have been the hotspot of research due to their simple operations,in line with 3Rs principles,and more stable results.However,owing to the complexity of experimental design and the lack of corresponding guidance,the research progress of alternative methods is slow.Recently,“Substitution of in vivo method(s) by in vitro method(s) for the quality control of vaccines” was adopted in the European Pharmacopoeia(10th Edition),which clarifies the critical points of consideration for substitution.This paper interprets the chapter and puts forward some thoughts on that in China,which is expected to speed up the alternative methods research and improve the ability of vaccine quality control and supervision in China.
