Navigating Late-Stage Comparability From Phase One to BLA Submission Through Strategic Planning & Regulatory Engagement

• Implementing proactive comparability strategies during late-stage development to manage process changes and scale-out requirements while maintaining condensed BLA timelines
• Transitioning products from early clinical phases through commercial readiness by establishing robust comparability frameworks that satisfy evolving regulatory expectations
• Leveraging successful comparability case studies and strategic regulatory navigation approaches to prevent delays and ensure seamless progression toward commercial approval

Speakers:

Mamta Kalra

VP Process and Analytical Development

Immatics Gmbh