How Process Enabling Closed Systems Offer Maximum Safety in ADC Manufacturing

Abstract

Since Antibody-drug Conjugates (ADC) are already approved for the treatment of relapsed Hodgkin’s lymphoma, HER2-positive metastatic breast cancer and B cell lymphoma, among others, high expectations are placed on this class of bioconjugates. Indeed, more than 100 different ADCs have been studied for various applications by 2022, presumably with several more to follow. Due to their composition, however, advanced risk management is necessary during ADC manufacturing, processing and transport. With a monoclonal antibody, a cytotoxic payload and a linker being their three main constituents, individual characteristics and risks of these three components have to be considered. In particular, but not limited to, cytotoxic payloads present unique challenges and pose considerable risks at multiple levels. Therefore, end-to-end solutions for bioconjugation processing are playing an increasing role in ADC processing and the task to cope with these challenges and provide a safe way to make the unique advantages of antibody-drug conjugates more accessible.