Antibody-drug conjugates (ADCs) are a class of pharmaceuticals that use an antibody to selectively deliver a cytotoxic drug to cancer cells. Critical quality attributes (CQAs) are controlled by means of the input quality of antibody and small molecule drug/linker components, as well as execution of the reduction/conjugation reaction and purification via Tangential Flow Filtration (TFF) within defined process parameter ranges. Therefore, it is critical to investigate the reactor and purification systems and determine scale up parameters for the ADC conjugation unit operations. This presentation will highlight how integrating experimental model systems and computational fluid dynamic modeling (CFD) can be utilized to understand how scale up parameters and manufacturing systems can impact quality attributes of the ADC.
