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.
Key Topics Include:
- Key guideline statements referenced for payload-linker CMC, and scientifically justified adjustments under technical constraints
- Route definition and RSM designation strategy for registration planning across clinical and commercial stages
- Stage-appropriate QC strategy from release testing and characterization to CQA-linked specifications, with impurity-control considerations
- Optimization considerations across purification, crystallization, lyophilization, ultrafiltration, and nanofiltration
Presenters
Head of Payload-Linker Team
Chemical Macromolecule Division (CMMD)
Asymchem
Webinar Host
AsymBio
