在O-phthalaldehyde的基础上量化结合疫苗中的多糖化物修饰
Burki Rajendar1, M V N Janardhan Reddy1, Ch N V Suresh1
1Research & Development, Biological E Limited, Shameerpet, Hyderabad 500078, India.
Journal of pharmaceutical and biomedical analysis
|February 3, 2024
概括
一种新方法量化了糖结合剂疫苗中的酸基,这对于确保疫苗稳定性和免疫性至关重要. 这一进步有助于制造T细胞依赖的婴儿疫苗.
科学领域:
- 疫苗开发 疫苗开发
- 免疫学 免疫学 免疫学
- 分析化学 分析化学
背景情况:
- 婴儿疫苗需要依赖T细胞的反应,而基于多糖的疫苗单独无法提供.
- 葡萄糖结合剂疫苗是通过将多糖与载体蛋白质结合而形成的,引起T细胞依赖免疫力,对婴儿免疫至关重要.
- 目前的制造方法,如还原性氨基化和基于CDAP的结合激活多糖基组,但量化CDAP激活组是具有挑战性的.
研究的目的:
- 开发和验证一种新的方法,用于量化通过CDAP化学激活的多糖体上的酸 Ester 组.
- 为了能够准确评估多糖激活程度,这对于合疫苗质量控制至关重要.
主要方法:
- 采用了一种涉及O-甲 (OPA) 衍生物化的新策略.
- 使用尺寸排除色谱 (SEC) 与高性能液态色谱 (HPLC) 进行分离.
- 紫外线检测被用来量化衍生的酸群.
主要成果:
- 开发的方法成功量化了活性多糖体上的酸 Ester 组.
- 这种技术可以直接评估多糖的激活/修饰程度.
- 也可以确定净化合物的残留活性基.
结论:
- 由SEC-HPLC-UV接下来的OPA衍生是一种可靠的方法,用于量化CDAP化学产生的酸群.
- 这种方法对于使用CDAP化学制造的葡萄糖合物疫苗的监测和质量控制至关重要.
- 准确的量化确保了婴儿疫苗接种的最佳结合疫苗稳定性和免疫性.
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