Nilaksh Gupta

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