Fireside chat: Scaling without compromise: Ensuring product comparability across sites and phases

Ensuring consistent product quality is critical as cell and gene therapies move from development to commercial supply. This session examines approaches to harmonize analytical testing, align quality control, and manage variability while accelerating timelines across multiple production sites. 

Key Takeaways 

• Align analytical methods and quality metrics across production sites 

• Implement strategies to maintain product consistency during scale-up and tech transfer 

• Manage variability in accelerated clinical and commercial supply timelines 

• Explore best practices for comparability assessments across sites and phases 

• Evaluate frameworks to support reproducible and compliant manufacturing at scale