Deba Saha
Director, CMC Regulatory Affairs AstraZeneca
Dr. Deba Saha is Director, CMC Regulatory Affairs at AstraZeneca, focusing on CMC regulatory strategy for dual payload ADCs, mAb based radioconjugates, and other mAb products. He previously led CMC regulatory strategies across many modalities of mAbs, cell and gene therapies, and mRNA LNPs in multiple therapeutic areas at Merck, Regeneron, Takeda, Sanofi, and Precigen, advancing assets to late stage and approval. He holds a PhD in Molecular Biology and an MBA and is based in Gaithersburg, USA.
Seminars
Monday 12th October 2026
Addressing ADC Regulatory Strategy for Gross Content Testing, Linker RSM Definition & Alternative Charge Variant QC for Release & Stability
9:30 am
- Overviewing a late stage ADC case study with a pragmatic workaround of Gross Content Testing to ensure reliable assessment without traditional testing
- Understanding regulatory strategy for defining and justifying RSMs for ADC linker-payloads
- Explaining an alternative to the conventional QC approach for charge-variant profiling of ADC drug substance and drug product for release and stability
