Abstract
Monoclonal antibody therapeutics possess high antigen specificity and structural stability, and they have been widely used in the treatment of cancer and autoimmune diseases. In recent years, antibody–drug conjugates（ADCs） have attracted attention as a novel modality with high therapeutic efficacy; however, their complex structures raise concerns regarding decreased stability. For the physicochemical evaluation of ADCs, Raman spectroscopy and dynamic light scattering（DLS） are effective techniques. Raman spectroscopy enables non-destructive analysis of structural changes and stability in highly concentrated formulations. DLS allows rapid evaluation of particle size changes during ADC production processes, making it possible to monitor reaction progress and aggregation states. These analytical methods contribute to quality control of ADCs and the optimization of manufacturing processes.
