Significant advances have been made in analytical technology for the characterization and identification of particles present in pharmaceutical products. With these advances comes a tremendous amount of new data with which to characterize biologics, devices, and small molecules. Careful interpretation of data and in-depth understanding of the method limitations is of utmost importance for using complementary methods to characterize particle profiles.
This presentation demonstrates how multiple particle techniques can be used to characterize therapeutic products and their particle populations. We provide case studies to highlight the advantages of particle methods for characterizing comparability and biosimilarity.