Formulation and Stability

Antibody-drug conjugates (ADCs) are highly potent, targeted-therapy compounds, designed to bind specifically to cancer cells of interest, minimize side effects, and provide a wider therapeutic window. They are starting to occupy an increasing portion of many biopharmaceutical companies' pipeline. This chapter focuses on stability, formulation, and logistical considerations for ensuring successful manufacture of ADCs. ADCs demonstrate reduced conformational stability compared to their parent monoclonal antibodies (mAb). All properties must be considered in designing an appropriate formulation for the ADC. The chapter also discusses the chemical stability of the linker-payload. mAb development has become routine and accelerated with the use of a platform approach; however, ADC development has been slowed down not only from technical challenges but also from manufacturing/logistical complexity in handling the various production steps. Advances in these areas are critical to enable the clinical application of ADC development to accelerate.