Integrating Extractables & Leachables Risk Management into Raw Material Control for Advanced Therapies

• 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

Speakers:

Charity Vilchez Juang

Senior Scientist, CMC Drug Substance Biologics

Bayer