Progress in the research and development of the methods for vaccine stability
10.3760/cma.j.issn.1003-9279.2018.04.021
- VernacularTitle: 疫苗稳定性方法研究进展
- Author:
Fan GAO
1
;
Kelei LI
1
,
2
;
Xing WU
1
;
Miao XU
1
;
Zhenglun LIANG
1
Author Information
1. National Institutes for Food and Drug Control, Beijing 102629, China
2. Minhai Biotechnology Co., Ltd, Beijing 102629, China
- Publication Type:Review
- Keywords:
Vaccine;
Stability;
Potency
- From:
Chinese Journal of Experimental and Clinical Virology
2018;32(4):426-429
- CountryChina
- Language:Chinese
-
Abstract:
The stability of vaccines has a major impact on the success of immunization programmes worldwide. Stability evaluation is a vital part of the assessment of the vaccine quality and safety. It should be regarded as a continuous process from the development of the vaccine through licensing to post-licensure monitoring. To ensure the quality of the vaccine, related guidelines were issued by both World Health Organization and Chinese regulatory authority. This paper reviews the progress of relevant guidelines and studies for providing the stability considerations of vaccine.
