From early clinical to commercial launch: building manufacturing pathways for success

Successfully moving therapies from first-in-human studies to commercial production involves aligning process development, quality systems, and facility capabilities. This discussion highlights approaches for designing manufacturing pathways that support scale-up, maintain product quality, and meet regulatory expectations. 

Key takeaways 

• Define critical elements of manufacturing pathways from clinical to commercial scale 

• Explore strategies to ensure process reproducibility and product consistency 

• Discuss integration of tech transfer and quality systems for smooth scale-up 

• Evaluate facility design and operational models that support growth 

• Review approaches to maintain compliance while accelerating time to market