2026.01.31
[Webinar] ADC Payload–Linker CMC Process Development Strategy
Webinar Invitation | ADC Payload–Linker CMC Strategy from IND to NDA As ADC programs become more complex, payload–linker CMC strategy is playing an increasingly critical role in determining the success of an IND-to-NDA journey. How do you design a robust, regulatory-aligned, and scalable CMC strategy while managing risk, quality, and manufacturability? Join us for an in-depth and practical webinar where Dr. Zheng Wei, Head of Payload-Linker Team at Asymchem CMMD, will share real-world insights on payload–linker CMC development across the entire lifecycle—from clinical development to commercial registration. What you’ll learn: • How payload–linker CMC planning differs between IND and NDA stages • Strategy for route design and regulatory starting material (RSM) selection • Stage-appropriate QC strategy linked to CQAs and impurity control • Practical optimization approaches for purification, crystallization, UF/NF, and lyophilization • How guideline interpretation can be scientifically adjusted under technical constraintsSpeaker:Zheng Wei, Ph.D.Head of Payload-Linker Team, Asymchem CMMDSupporting 70+ INDs and 13 NDAs with extensive experience in high-potency and novel payloads, complex linkers, and GMP manufacturing. Register Here: https://us06web.zoom.us/webinar/register/4017702578362/WN_gvROIdYHSwC73a3B9WaWwQ
