Key points:
Gene therapy overview and market trend
Regulatory (CMC) challenges for gene therapy products
Quality-by-Design: Regulatory requirement and high-level framework
Implementing QbD for gene therapy products (AAV example):
Current industry platform manufacturing methods
Considerations for Critical Quality Attributes, Critical Process Parameters and Material Attributes
Considerations for Control and Testing Strategies
Led by:
Peiqing Zhang, Strategic Technology Partnership Leader Cell and Gene Therapy, APAC, Pall Corporation, Singapore