Xiaoying Ye
Senior Scientist AstraZeneca
Seminars
Wednesday 29th April 2026
Panel Discussion: Pushing the Limits of Analytics for Invisible Heterogeneity & In-Process Control To Expand the Characterization Frontier
12:00 pm
Looking beyond current techniques to debate the next frontier in characterization, from continuous manufacturing control to analyzing single molecules. This panel discussion will challenge the status quo on what is “good enough” and explore the technologies that will redefine our understanding of ADC structure by:
- Speculate on the potential of single-molecule sequencing and mass spectrometry to fully resolve ADC populations, and whether this ultimate level of characterization is a necessary future standard or an analytical fantasy
- Debate the hurdles and rewards of implementing real-time PAT and in-line analytics for continuous ADC manufacturing, moving from batch release to a state of perpetual verification
- Explore the role of computational models and AI in predicting ADC biophysical behavior and long-term stability from early structural data, potentially rendering months of stability studies obsolete
Tuesday 28th April 2026
Mastering Physiochemical Analysis to Advance Strategies for DAR, Charge Variant, & Stability Characterization of Complex ADCs
Diving into practical strategies to overcome key analytical hurdles in drug distribution and charging variant analysis, moving from simple average measurements to a deep understanding of product quality. A mustattend to deconvolute ADC complexity and build robust, regulatory-ready control strategies by:
- Comparing data from HIC, reversed-phase LC-MS, and native MS for a heterogeneous ADC to select the optimal orthogonal methods to confidently characterize and control drug load distribution for regulatory filings
- Rethinking charge variant analysis using capillary electrophoresis and imaged CIEF to accurately monitor critical product attributes like deamidation and implement a fit-for-purpose control strategy meaningful for ADCs
- Developing a control strategy for dual-payload ADCs, covering site-specific and branched linker formats, to design robust analytical control plans for these next-generation modalities and accelerate their development path
