Advances In ADC Development And Manufacturing

Antibody-drug conjugates (ADCs) are evolving rapidly, with more complex modalities creating added challenges across development and manufacturing. This presentation explores how manufacturers can respond by considering manufacturability earlier and tailoring process strategies to the final antibody-linker-payload combination. It highlights the need for flexible purification, formulation, and facility approaches that address increasing molecular complexity while supporting product quality and scalable production.

The presentation also examines the role of closed single-use systems, integrated automation, and fit-for-purpose facility design in reducing operator interaction with high-potency materials. Alongside operator protection, it emphasizes patient safety through process-specific extractables and leachables assessments aligned with USP <665>. Together, these approaches support a more connected ADC manufacturing workflow that brings process control, containment, scalability, and risk management into one strategy.