Hear Dr. Zheng Wei share a comprehensive payload-linker CMC development strategy that covers regulatory guidance, RSM selection, and stage-appropriate quality control to navigate the evolving complexities of ADC design from IND to NDA.

With expanding ADC programs and more complex conjugate designs, payload-linker CMC strategy can be decisive for a program's IND-to-NDA path. As this novel modality continues to develop rapidly, innovative and AI-enabled responsive linkers, highly toxic payloads with low immunogenicity, and site-specific glycoconjugation techniques are receiving increasing attention. In this webinar, Dr. Wei highlights four areas of the CMC development strategy: guidance and interpretation, route design and principles for regulatory starting material (RSM) selection, stage-appropriate quality control (QC) strategy, and separation/purification process optimization.

The session highlights how payload-linker CMC planning differs between clinical supply and commercial registration, and what drives route definition and RSM designation. An IND versus NDA filing strategy example is used to illustrate stage-appropriate route planning. The session also explains how QC expectations move from release testing and characterization to CQA-linked specifications, with optimization considerations mapped to a typical process flow.