Day One

• Implementing phase-appropriate comparability strategies from phase one through phase three to maintain product consistency while transitioning from manual to automated processing
• Navigating critical process changes including automation of culture operations to balance regulatory expectations with commercial manufacturing scalability and cost effectiveness
• Establishing robust comparability frameworks early in development to prevent late-stage regulatory setbacks when integrating closed automated systems for commercial transition

• Transitioning from manual to automated manufacturing processes across clinical phases to reduce operator variability and enhance product reproducibility
• Deploying real-time monitoring and data aggregation systems to capture critical process parameters and enable immediate corrective actions during production
• Overcoming automation integration challenges when scaling from early clinical phases to mid-stage manufacturing while maintaining process comparability and regulatory compliance

As the cell therapy process development community is reunited, this valuable session will ensure you get the chance to reconnect with peers and make brand new connections.

This structured networking opportunity will pair you with fellow attendees for several 3-minute introductions, ensuring you have the opportunity to meet and network with your industry colleagues.

• Balancing automation benefits including reduced variability and increased throughput against potential risks to product quality during technology transitions
• Establishing robust quality control strategies and in-process monitoring to ensure automated systems maintain or exceed manual process quality standards
• Navigating vendor selection and validation challenges to identify automation platforms that preserve critical quality attributes while improving manufacturing efficiency

• 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

• Initiating early product and process lifecycle mapping to identify optimal timing for changes while leveraging FDA guidelines emphasizing flexibility in early phases versus stringent late-stage expectations
• Implementing robust statistical justification strategies and collaborating with statisticians to overcome analytical challenges and support regulatory-compliant comparability assessments
• Applying risk management frameworks in stepwise approaches to tackle potential showstoppers early and facilitate smoother transitions throughout process development activities

Witness some of the latest and greatest cell therapy process development contributions by drug developers, academics, researchers, and platform developers in this spotlight poster session.

• Structuring data capture systems and databases to aggregate clinical manufacturing runs and enable meaningful analysis of process performance trends
• Applying aggregated data to develop predictive models for process yield, cell expansion, unit operation recovery, and process timing
• Identifying critical process parameters and performance gaps through data analysis to guide optimization and improve robustness

• Addressing the cell therapy automation paradox by determining optimal implementation timing since fully automated closed systems remain expensive and impractical for early research-scale development
• Balancing custom automation development versus leveraging existing unit operation technologies to avoid reinventing the wheel while maintaining regulatory and business viability
• Securing full organizational buy-in and strategic planning upfront to prevent late-stage automation failures from agency requirements or internal business challenges after significant investment