From Discovery To Patients: An Integrated Service For ADC Development By Lonza And Synaffix

By Peter Tjeerdsma, Head of Synaffix CMC and Regulatory Affairs, Lonza; and Raphael Frey, Ph.D., Director, Commercial Development, Bioconjugates, Lonza

Antibody-drug conjugates (ADCs) combine the targeting precision of antibodies with potent cytotoxic payloads, enabling selective treatment of cancer and other diseases. Yet designing a safe, effective ADC remains notoriously difficult: an unstable construct can release its payload prematurely, exposing healthy tissue and causing serious side effects. Development is further complicated by the need to coordinate the many specialized manufacturers responsible for each component — adding delay to an already demanding path.

This paper outlines how site-specific conjugation, paired with an integrated development and manufacturing program, can help overcome these hurdles. It describes how standardized, stable linker-payload options enable earlier de-risking of candidate molecules, and how a coordinated supply chain and streamlined timeline can advance an ADC from initial design to an investigational new drug (IND) application in as little as 15 months. For teams running an ADC program, it offers a practical view of where delays typically arise and how an end-to-end approach can keep a promising molecule moving efficiently toward the clinic.