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基于布拉德福德的蛋白质定量方法的系统开发和验证,用于新型多剂量R21疟疾疫苗,配合2-乙醇 (2-PE) 配制

Rajender Jena¹, Dnyanesh Ranade¹, Prajwal Chaudhari¹

¹Quality Control Department, Serum Institute of India Pvt. Ltd., Hadapsar, Pune 411028, Maharashtra, India.

|January 28, 2026

概括

一种新的布拉德福德测定方法准确量化了R21疟疾疫苗抗原,确保了这一重要的公共卫生工具的质量控制. 这种可靠的方法通过验证疫苗功效来支持全球疟疾预防工作.

科学领域:

疫苗学疫苗学疫苗学
蛋白质化学蛋白质化学
分析化学分析化学

背景情况:

下一代工具R21疟疾疫苗需要精确的蛋白质量化来控制质量,特别是在复杂的配方中.
由于抗原度低以及辅助剂和防腐剂的存在,精确量化具有挑战性.
多剂量疫苗呈现方式是大规模免疫计划的首选,如扩展免疫计划 (EPI).

研究的目的:

评估和选择一个合适的蛋白质估计方法来量化R21疟疾疫苗抗原.
根据国际准则,优化和验证所选择的蛋白质量化方法.
确保R21疫苗制造和批发的质量控制的可靠性.

主要方法:

微-BCA,BCA和布拉德福德试验对R21抗原量化的比较评估.
根据精度,准确性和线性选择布拉德福德试验.
方法优化,根据ICH Q2 (R2) 准则进行验证,并评估特异性,准确性和精度.

主要成果:

优化的布拉德福德试验证明了高的特异性,准确性和精度,定量界限 (LOQ) 为2μg/mL.
该试验显示了检测抗原度变化的灵敏度和与ELISA可比的性能.
在释放和稳定性研究中,量化蛋白质含量与强大的体内免疫性相关.

结论:

经过验证的布拉德福德试验为R21疫苗质量控制提供了快速,经济有效和高吞吐量解决方案.
该方法为基于复杂病毒样粒子 (VLP) 的疫苗的质量控制设定了新的基准.
测试的稳定性支持全球疟疾预防计划所需的精度和可靠性.

关键词:

2-基乙醇 (2-PE) 是一种二氧化乙醇.布拉德福德测定方法 R21 疟疾多剂量疫苗免疫性免疫性免疫性矩阵 M1 是一个矩阵.蛋白质估计估计蛋白质估计类似病毒的粒子 (VLP)

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