Differential scanning calorimetry: Robust and powerful physical characterization of therapeutic protein products

Differential scanning calorimetry (DSC) is a robust and powerful physical method for characterizing the thermal stability of proteins. During the life history of a commercial therapeutic protein product, DSC analysis is uniquely valuable from early discovery research to commercial product management. Areas in which DSC is used include: comparing stability of potential drug candidates; conducting preformulation and formulation screening studies; biophysical characterization of drug product for regulatory filings; comparability studies after a manufacturing change; and comparing a biosimilar to an innovator drug product. DSC analysis of a protein also can provide insightful data in investigations of the roles of specific domains in the instability and aggregation of multidomain proteins.

In this webinar, some examples of these applications will be described. In addition, results from studies on the effects of heating rate will presented, which demonstrate that faster heating results in both increased sample throughput and increased method sensitivity. Finally, data will be presented from a recent biophysical comparison of antibody drug conjugates to the parent antibody. These results documented that important differences in thermal stability could readily be resolved and quantified with DSC; whereas during heating studies with various spectroscopic techniques no differences were discernable.