Jack Ren
Global Director - Downstream Process Development & CMC Development Ultragenyx Pharmaceutical Inc.
Seminars
Thursday 25th February 2027
Leveraging Platform & Prior Knowledge for Accelerated PPQ Campaign & Commercial Readiness Under Compressed CMC Timelines
12:15 pm
- 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
