论文标题
通过全息表征，蛋白质聚集体与其他亚细颗粒的蛋白质聚集体的定量分化
Quantitative differentiation of protein aggregates from other subvisible particles in viscous mixtures through holographic characterization
论文作者
论文摘要
我们证明了使用全息视频显微镜来检测分散在生物制药配方中的单个可见颗粒，并根据从全息图中测量的材料特征来区分它们。全息分析的结果是对同时分散在同一产品中的多种可见污染物的浓度和大小分布的精确测量。我们通过在存在常见污染物（例如硅油乳液液滴和脂肪酸）的情况下对由人IgG聚集体组成的模型系统进行测量来证明这种分析技术。全息视频显微镜还清楚地识别了金属颗粒和气泡。能够区分和表征这种异质性分散体的各个组件为跟踪影响蛋白质制剂稳定性的其他因素提供了一个基础，这些因素包括处理和降解表面活性剂和其他赋形剂。
We demonstrate the use of holographic video microscopy to detect individual subvisible particles dispersed in biopharmaceutical formulations and to differentiate them based on material characteristics measured from their holograms. The result of holographic analysis is a precise and accurate measurement of the concentrations and size distributions of multiple classes of subvisible contaminants dispersed in the same product simultaneously. We demonstrate this analytical technique through measurements on model systems consisting of human IgG aggregates in the presence of common contaminants such as silicone oil emulsion droplets and fatty acids. Holographic video microscopy also clearly identifies metal particles and air bubbles. Being able to differentiate and characterize the individual components of such heterogeneous dispersions provides a basis for tracking other factors that influence the stability of protein formulations including handling and degradation of surfactant and other excipients.
