Artificial Intelligence and Computational Statistics Platform for Biosimilar Subvisible Characterization
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Who can apply
No Set aside used. NONE
About this opportunity
The Food and Drug Administration�s Office of Product Quality Research (OPQR) require a machine learning (ML/AI) and computational statistics platform with associated services to detect and classify protein aggregates in 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 machine 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 different stress types, the product, and co...