Stability of Protein-Sugar Lyophilizates Investigated with Terahertz Spectroscopy

Understanding of the molecular mobility in freeze-dried matrices is of high importance for the assessment and prediction of the stability of lyophilized biotech drugs. In this project, lyophilizates of different sucrose to monoclonal antibody (mAb) ratio are assessed with terahertz spectroscopy to determine the mobility of the glassy sugar/protein matrix. Upon increasing the amount of mAb present, the behavior deviates from that of well-known small molecular systems. Samples containing more than 75% mAb show an interesting feature at about 300K that requires further characterization.