评价候选人的国际标准为脑膜炎球菌囊多糖群W和Y组
Hannah Chan1, Nicola Beresford1, Timothy R Rudd2
1Division of Bacteriology, National Institute for Biological Standards and Control, Blanche Lane, Potters Bar, Hertfordshire, EN6 3QG, UK.
概括
对脑膜炎球菌W和Y多糖的两个候选国际标准进行了评估. 这些标准将有助于标准化疫苗量化,在36个月内显示一致的内容.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 生物化学 生物化学
- 分析化学 分析化学
背景情况:
- 疫苗的标准化对公共卫生至关重要.
- 脑膜炎球菌疫苗需要精确量化多糖抗原.
- 现有的标准可能无法完全满足MenW和MenY量化需求.
研究的目的:
- 评估两个候选国际标准对脑膜炎球菌W (MenW) 和Y (MenY) 多糖的适用性.
- 建立用于疫苗生产和质量控制的MenW和MenY多糖的定量标准.
- 为了验证这些标准在疫苗成分的物理化学测定中的使用.
主要方法:
- 一项涉及来自11个国家的12个实验室的合作研究.
- 对MenW多糖体 (16/152) 和MenY多糖体 (16/206) 的候选国际标准的评估.
- 使用Resorcinol试验进行量化,以分配单位数量.
主要成果:
- 候选的MenW多糖标准 (16/152) 赋予了每片1.015±0.071毫克的含量.
- 候选MenY多糖标准 (16/206) 的含量为0.958±0.076毫克/瓶.
- 在各种条件下,多糖含量在36个月内保持稳定.
结论:
- 候选制剂适合作为MenW和MenY多糖的国际标准使用.
- 这些标准将有助于在疫苗和中间产品中精确量化MenW和MenY多糖.
- 稳定性数据支持这些拟议标准的长期实用性.
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