Subvisible particle analysis can reveal stability issues when other techniques lack sensitivity
During the candidate selection phase, information about properties such as aggregation behavior, hydrophobicity, and stability is needed. Techniques used to predict protein stability during developability assessment or pre-formulations typically measure smaller, soluble aggregates and protein unfolding/Tm. However, relying on information from such methods as SEC, DLS, MALS, or iso-electric focusing is limiting and can mean potentially missing critical information on aggregate particles. Measuring in the subvisible range can reveal issues that would otherwise remain undetected.