CMC Strategies to Scale Gene Therapy for Common Diseases: A Roadmap to Quality and Efficiency
Time: 11:00 am
day: Focus Day
Details:
• Process Innovation for High-Volume Production: Leveraging modular production and advanced technologies to meet the demands of large-scale gene therapy applications in common diseases
• Building a Quality-Driven Manufacturing Framework: Establishing robust analytics, in-process controls, and release testing to ensure product consistency at scale
• Integrating Cost-Effective CMC Solutions: Developing strategies for streamlined process validation, risk-based testing, and cost-efficient supply chains tailored for broader patient populations
