Leveraging Advanced Analytical Capabilities to Derisk Drug Development

As biotherapeutic molecules continue to grow increasingly complex, it is vital for sponsors to have a thorough understanding of structural properties and product- and process-related impurities to create thorough regulatory submissions. For example, the use of fusion proteins and bispecific molecules in therapeutics has necessitated a more diverse analytical toolbox, including mass spectrometry, biophysical characterization, automated sample preparation, and high throughput analytics. Beyond helping to ensure compliance, gaining an early understanding of a molecule’s characteristics informs strategy and decision-making throughout the product development cycle.