Artificial Intelligence and Computational Statistics Platform for Biosimilar Subvisible Characterization

biosimilar drug products. This capability will support a feasibility study assessing the utility of artificial intelligence/machine learning and computational statistical analysis for biosimilar comparability assessment, quality assessment, and quality surveillance. The platform: � Shall combine mac

hine learning to generate morphological fingerprints of protein aggregates � Shall generate morphological fingerprints specific to product and underlying stress or mechanism of aggregation � Shall be able to differentiate particles from dif