Characterization of Biopharmaceutical Stability with Differential Scanning Calorimetry

This Malvern white paper focuses on the use of differential scanning calorimetry (DSC) to characterize the thermal stability of protein biopharmaceuticals (primarily antibodies), and as a higher order structure (HOS) characterisation tool for the comparability of biopharmaceuticals and for the development of biosimilars. Using DSC results, biopharmaceutical companies can ensure each batch of protein is highly similar to the reference lot, and that any process or manufacturing changes do not affect the conformational protein stability.