期刊
VACCINES
卷 9, 期 3, 页码 -出版社
MDPI
DOI: 10.3390/vaccines9030229
关键词
outer membrane vesicles; GMMA; stability; vaccine
资金
- U.K. Department of Health and Social Care [EP/R013764/1]
- EPSRC [EP/R013764/1] Funding Source: UKRI
Research has shown that high temperature conditions do not affect the stability and immunogenicity of GMMA, but longer periods of low temperature conditions may have an impact. Monitoring critical quality attributes during stability assessment is crucial for vaccine efficacy.
Ensuring the stability of vaccines is crucial to successfully performing global immunization programs. Outer Membrane Vesicles (OMV) are receiving great attention as vaccine platforms. OMV are complex molecules and few data have been collected so far on their stability. OMV produced by bacteria, genetically modified to increase their spontaneous release, simplifying their production, are also known as Generalized Modules for Membrane Antigens (GMMA). We have performed accelerated stability studies on GMMA from different pathogens and verified the ability of physico-chemical and immunological methods to detect possible changes. High-temperature conditions (100 degrees C for 40 min) did not affect GMMA stability and immunogenicity in mice, in contrast to the effect of milder temperatures for a longer period of time (37 degrees C or 50 degrees C for 4 weeks). We identified critical quality attributes to monitor during stability assessment that could impact vaccine efficacy. In particular, specific recognition of antigens by monoclonal antibodies through competitive ELISA assays may replace in vivo tests for the potency assessment of GMMA-based vaccines.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据