调节电阻脉冲传感 (TRPS) 技术用于疫苗配方中的颗粒大小分布的评估 - - 一项使用动态光散射进行比较研究
Rahul Misra1, Ginny Fung2, Siddhant Sharma2
1Vaccine CMC Development and Supply, Analytical Sciences, Sanofi, Toronto, Ontario, M2R 3T4, Canada. rahul.misra@sanofi.com.
Pharmaceutical research
|April 22, 2024
概括
可调节电阻脉冲传感 (TRPS) 为疫苗配方提供颗粒对颗粒的分析,补充动态光散射 (DLS),通过提供更精确的尺寸表征和分辨聚散样本中的聚合物.
科学领域:
- 纳米技术 纳米技术
- 生物技术是生物技术.
- 分析化学 分析化学
背景情况:
- 精确的颗粒大小测定对于疫苗配方开发和质量控制至关重要.
- 传统的动态光散射 (DLS) 提供了基于集体的测量,但可以面临多分散样本的局限性.
- 像可调节电阻脉冲传感 (TRPS) 这样的新兴技术提供了粒子对粒子的分析,在分辨率和精度方面提供了潜在的优势.
研究的目的:
- 为了比较评估DLS和TRPS对于疫苗配方的颗粒大小测量能力.
- 确定每个技术的局限性,包括混合群体中的仪器可变性,灵敏度和分辨率.
- 评估三个不同的疫苗配方作为案例研究.
主要方法:
- 同时评估三种内部疫苗配方 (蛋白质抗原,外膜囊泡,病毒颗粒).
- 使用了基于TRPS的EXOID和两个DLS仪器 (Zetatrac,Zetasizer).
- 评估了多分散物种的粒子大小分布,聚合物和分辨率.
主要成果:
- DLS可能会高估多分散样本中的粒子大小和平均结果;TRPS解决了这一问题,但具有大小范围的限制.
- 在两个DLS仪器之间观察到敏感度的显著差异.
- 与DLS相比,TRPS在多分散疫苗样本中显示出大型聚合物种的优异分辨率.
结论:
- 对于传统的DLS来说,TRPS是一种有价值的直角技术,用于精确的疫苗表征.
- 无论是DLS还是TRPS都是有效的尺寸表征,产生可比的结果.
- 最佳的技术选择取决于特定的疫苗配方和感兴趣的尺寸范围.
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