Pre-Conference Day

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

Delve into translating biological complexity into robust, reproducible, and relevant bioassays that accurately reflect clinical function. Join this workshop to prove the functional integrity of next-generation ADCs & AOCs and meet regulatory expectations for critical quality attributes by:

• Deconstructing a complex ADC & AOC mechanism of action into testable functional units, ensuring the resulting potency assay is biologically relevant and measures the activity, leading to robust, meaningful potency methods
• Selecting and engineering of reproducible cell lines, focusing on promoter strength and banking strategies, to create a stable foundation that minimizes bioassay variability and ensures consistent, reliable potency data
• Designing bioassays for bispecific and dual-payload ADCs & AOCs to address the critical challenge of proving dual-target engagement, controlling complex modalities, and demonstrating functional integrity

Join this workshop to learn the best strategies for detecting impurities, executing risk assessments and setting defensible specifications, to de-risk development programs and build compelling regulatory justifications by:

• Applying small molecule elucidation tools (HR-MS, MS/MS, NMR) to identify novel payload degradation products, to characterize unknown impurities, understand formation pathways, and mitigate risks to product stability and safety for ADCs and AOCs
• Using real-world examples of ADC and AOC process and product-related impurities to learn systematic methods for classifying impurities based on conjugatability, toxicity, and purgeability, and to build a scientifically justified risk assessment for regulators
• Leveraging analytical techniques like HIC and develop a data-driven package of purge studies for nonconjugatable impurities to justify impurity limits, navigate regulatory uncertainty, and and confidently set and defend science-based specifications that ensure patient safety