Edwin Lozano
Associate Scientist Oligonucleotide Denali Therapeutics Inc.
Seminars
Tuesday 28th April 2026
Controlling Impurities Through Identification & Risk Assessment To Set Justifiable Specifications for Robust ADC & AOC Development & Streamlined Regulatory Success
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
