Leveraging Platform & Prior Knowledge for Accelerated PPQ Campaign & Commercial Readiness Under Compressed CMC Timelines

• Establishing risk-based process characterization strategies using platform knowledge to accelerate development activities without compromising regulatory expectations
• Implementing streamlined PPQ planning and execution approaches to achieve manufacturing readiness despite limited time, historical data and resources
• Applying platform-derived control strategies to strengthen regulatory submissions, expedite CMC preparedness and support successful product approval

Speakers:

Jack Ren

Global Director - Downstream Process Development & CMC Development

Ultragenyx Pharmaceutical Inc.