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

• Implementing automation-capable manufacturing solutions to reduce operator variability and lower cost of goods while maintaining GMP compliance throughout production
• Deploying flexible GMP reagents for T cell workflows to accommodate emerging requirements and enable process optimization across therapeutic modalities
• Leveraging single-use bioreactor systems designed for cell therapy to standardize culture conditions and facilitate clinical-to-commercial technology transfer

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.

• Addressing the limitations of conventional 2D expansion workflows when cell therapy processes need to move towards closed, scalable and reproducible manufacturing
• Exploring how Osilaris™ supports controlled low-shear expansion with in-line process control to help maintain process-relevant quality attributes
• Discussing how automation-ready bioreactor processing can support clinical-to-commercial progression, decentralised manufacturing models and lower process variability

• 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

• Optimizing cryopreservation and thawing protocols to minimize cell loss and maintain viability for consistent downstream processing
• Classifying donors and implementing manufacturing adaptations based on variability to control process parameters and ensure product quality
• Coordinating between process development and analytical teams to secure sufficient quality material for validation, qualification, and robust testing

• 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

• Developing risk assessments to justify and guide process characterization strategy
• Designing and executing statistically sound experiments (DOE) to identify critical process parameters (CPPs) and establish Proven Acceptable Ranges (PARs)
• Applying real‑world lessons learned to anticipate challenges and avoid common process characterization pitfalls

• What is the value of using small-scale models in process development?
• How can developers establish and qualify small-scale models?
• To what extent do the regulations support the use of small-scale models in process development?

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