Panel: Analytics, In-Process Control & Quality Control in Advanced Therapies

Effective analytics and quality control are essential for ensuring product consistency, safety, and regulatory compliance in advanced therapies. This panel examines approaches to develop fit-for-purpose assays, leverage advanced monitoring platforms, and navigate process or raw material changes during development. 

Key takeaways: 

• Design potency assays that are fit-for-purpose and meet regulatory expectations 

• Leverage advanced platforms for in-process monitoring, stability assessment, and release testing 

• Manage process or raw material changes without triggering regulatory setbacks 

• Evaluate strategies to maintain data integrity and reproducibility across development stages 

• Discuss integration of analytics and quality control to support scalable manufacturing