Conjugation Process Development and Scale-Up

Manufacturing highly potent antibody–drug conjugates (ADCs) is a demanding task—combining conventional organic synthesis with biotechnological manufacturing. Hence a series of new and unique engineering and chemistry challenges have to be addressed to support clinical trials and commercial manufacturing. These include the development of reliable processes leading to uniform product properties, as well as establishment of ADC-specific analytical methods and safe strategies for handling cytotoxic compounds. This review focuses on process development and scale-up for the production of ADCs and highlights the most important features in such a process.