Development of Commercial-Ready Processes for Antibody Drug Conjugates

As antibody drug conjugates (ADCs) move through clinical development, from phase 1 to pivotal studies, supported by clinical efficacy and appropriate safety, the development of late stage and commercial-ready processes and methods becomes a priority. During the development of early stage processes, the focus is on speed, consistency, and quality. For later stage development, additional aspects need to be considered including process robustness, cost effectiveness, process and method transferability, and an integrated control strategy as a foundation for the regulatory filing.