Aggregation is a critical parameter for protein-based therapeutics, due to its impact on the immunogenicity of the product. The traditional approach towards characterization of such products is to use a collection of orthogonal tools. However, the fact that none of these tools is able to completely classify the distribution and physical characteristics of aggregates, implies that there exists a need for additional analytical methods. We report one such method for characterization of heterogeneous population of proteins using transmission electron microscopy. The method involves semi-automated, size-based clustering of different protein species from micrographs. This method can be utilized for quantitative characterization of heterogeneous populations of antibody/protein aggregates from TEM images of proteins, and may also be applicable towards other instances of protein aggregation.

聚集是基于蛋白质的治疗方法的关键参数，因为它会影响产品的免疫原性。表征此类产品的传统方法是使用正交工具的集合。但是，这些工具都无法完全对聚集体的分布和物理特征进行分类，这一事实表明存在对其他分析方法的需求。我们报告了一种使用透射电子显微镜表征蛋白质异质群体的方法。该方法涉及从显微照片中对不同蛋白质种类进行基于大小的半自动聚类。此方法可用于从蛋白质的TEM图像定量表征抗体/蛋白质聚集体的异质群体，