Scientific Program Manager National Institutes of Health
This presentation will provide an overview of the ideal position for cGMPs throughout the cell therapy product life cycle. GMPs become more rigorous as the cell therapy product advances from discovery/R&D, clinical trials, and commercial launch. A Phase-Appropriate approach allows the supply of safe clinical materials for studies in humans while maintaining manufacturing flexibility at noncommercial scales and during scale-up and process transfer to commercial facilities.
Learning Objectives:
Understand the CMC regulatory compliance requirements and expectations (FDA, EMA, ICH) for cell therapy products during clinical development and market approval
Evaluate the strengths and limitations of Quality by Design and Quality Risk Management for cell therapy manufacturing processes
Assess phase-appropriate CMC strategies for cell therapy products
