Charity Vilchez Juang
Senior Scientist, CMC Drug Substance Biologics Bayer
Seminars
Tuesday 27th October 2026
Integrating Extractables & Leachables Risk Management into Raw Material Control for Advanced Therapies
11:15 am
- Developing a risk-based framework to prioritize single-use components based on product contact, process criticality, and CGT-specific manufacturing considerations
- Translating supplier extractables data into clinically relevant exposure assessments using process parameters, material contact conditions, and patient-dose scenarios
- Leveraging thresholds and toxicological risk assessment(s) to determine when additional testing is needed while maintaining patient safety
