Process characterization is an important step in the overall journey of product development. For therapies that have had early success in the clinic and are progressing toward commercial manufacturing, understanding the operational, regulatory and quality connections is critical for successful filing and launch.

This case study proposes an approach for process characterization for the
production of a monoclonal antibody, specifically at the drug substance biomanufacturing step. This approach will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.