Scaling without compromise: ensuring product comparability across sites and phases

Scaling advanced therapies requires careful alignment of processes, analytical methods, and quality systems to ensure product integrity is maintained. This discussion focuses on practical approaches for multi-site manufacturing, bridging clinical phases, and implementing robust comparability frameworks that support reproducible outcomes. 

Key takeaways 

• Identify critical parameters for maintaining product comparability across sites and phases 

• Explore analytical and process control strategies to monitor consistency 

• Discuss standardization approaches for multi-site manufacturing 

• Evaluate risk management strategies during scale-up transitions 

• Review frameworks for regulatory alignment and quality assurance