Scott Baggett
Principal Director Former Sutro Biopharma
Seminars
Wednesday 29th April 2026
Leveraging Small Molecule Elucidation Tools for ADC Payloads for Improved Payload Degradation Detection
2:30 pm
- Apply high-resolution mass spectrometry and MS/MS fragmentation to payload degradation products, to propose potential structures for novel species, enabling proactive identification and risk assessment of new impurities
- Leverage NMR spectroscopy for definitive structural elucidation, to unambiguously identify the chemical structure of major degradation products, providing the highest level of confidence for regulatory filings and understanding structure-activity relationships
- Utilize software tools designed for small molecule structure elucidation, to automate data analysis and hypothesis generation, accelerating the identification process and bridging the analytical gap
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
