Abstract

The design and development of an ADC requires knowledge and understanding of the underlying biology as well as of the chemistry involved. The design has a significant impact on the PK/PD, toxicity as well as on the physico-chemical properties that impact the product formulation. Analytical complexity is significantly magnified relative to that for a mAb. Addressing manufacturing and regulatory issues involves consideration of biotherapeutics as well as small molecules perspectives. Manufacturing ADCs involves facilities with the capability to handle high potency materials. In order to assemble the ADC, its constituent parts (mAb, Linker, Payload) must be brought together and conjugated, purified, stored and subsequently shipped to the drug product facility. The logistics of such an operation must be seamless to prevent loss as well as safety concerns. This presentation provides an overview of design aspects of ADCs and the resultant impact on CMC development. The manufacturing process will also be considered with a focus on the drug product.