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