Accelerating ADC Analytical Method Development Through Platform Innovation

By Jaeook Kim, Associate Director, ADC Analytical Development

Antibody–drug conjugate (ADC) modalities are rapidly evolving, with increasingly complex formats, novel linker-payload combinations, and accelerated development timelines reshaping the biopharmaceutical landscape. As a result, analytical development teams face growing pressure to deliver comprehensive characterization strategies within compressed schedules while maintaining regulatory rigor and product quality. Achieving investigational new drug (IND) readiness, therefore, depends on the early identification and assessment of critical quality attributes (CQAs), enabling informed decision-making and proactive risk mitigation throughout development.

To address these challenges, Samsung Biologics has established a platform-based analytical development strategy designed to balance standardization with scientific flexibility. By leveraging platform knowledge, fit-for-purpose analytical methods, and adaptable characterization workflows, the approach supports efficient evaluation of diverse ADC candidates while accommodating molecule-specific requirements. This strategy enables greater predictability in development timelines, reduces technical and regulatory risks, and streamlines the transition from early-stage development to clinical manufacturing and patient delivery.