Neural network–based fingerprinting of monoclonal antibody aggregation using biolayer interferometry

Aggregates are widely accepted to be a critical quality attribute (CQA) for biotherapeutics and believed to impact product immunogenicity. Monitoring of aggregates is typically performed using multiple orthogonal tools as any single tool is unable to offer comprehensive characterization of aggregate species over the entire size and morphology range that they can exist in. Researchers have attempted to categorize monoclonal antibody (mAb)...