8:00 am Check-In & Coffee
8:55 am Chair’s Opening Remarks
9:00 am Maximizing Automation for Scalable Cell Therapy Production: An Overview of Automation in 2025
Synopsis
- Linking Processes with Automation: Integrating robotics to optimize efficiency across various stages of cell therapy production, reducing manual interventions
- Scaling Up Production with Automation: Exploring automation solutions for high-throughput processing and large batch handling to meet increasing demand
- Cutting-Edge Automation Tools: Reviewing robotic arms, automated material handling, and quality control technologies to ensure consistent, scalable production
- Post-Approval Automation Strategies: Addressing the challenges of automating established commercial processes while maintaining regulatory compliance and patient safety
Strategies for Success Through Overcoming Barriers to Scalability & Commercialization
9:30 am Manufacturing CAR-T Cells Using Whole Blood Collection
Synopsis
- Stability of whole blood material
- At-scale processing using whole blood from healthy donors
- Donor-matched leukapheresis and whole blood side-by-side processing
10:00 am Navigating the Challenges of Rare Cell Populations & Limited Raw Materials in Cell Therapy
Synopsis
- Addressing the difficulty in sourcing rare or specialized cell populations, and the impact on therapy development
- The limitations of standard bioreactor-based processes and the need for tailored approaches to expand, differentiate, and scale rare cell populations
- Overcoming challenges in cryopreserving rare cell types, developing stable formulations, and managing limited raw material availability for effective therapeutic dosages
10:30 am Morning Break & Networking
11:30 am Scaling Up Allogeneic Cell Therapy: Tackling Manufacturing, Quality, & Regulatory Hurdles
Synopsis
- Process Development and Scalability: Overcoming challenges in cell expansion, automation, and closed-system manufacturing to enable commercial-scale production
- Quality and Consistency: Strategies to maintain cell viability, potency, and purity across large-scale bioreactor platforms while managing donor variability
- Regulatory and Supply Chain Challenges: Addressing GMP compliance, cryopreservation logistics, and end-to-end supply chain optimization for global distribution
12:00 pm Case Study: Overcoming Process Development Challenges in Solid Tumor- Targeting Cell Therapies
Synopsis
- Tumor Heterogeneity and Microenvironment: Exploring strategies to address tumor antigen variability and immunosuppressive tumor microenvironments for improved cell therapy efficacy
- Scalability and Manufacturing Optimization: Tackling challenges in scaling production and ensuring consistent quality for high-throughput, large-scale manufacturing of solid tumor therapies
- Safety and Potency Control: Innovating with safety mechanisms and advanced potency assays to prevent off-tumor toxicity and ensure functional cell activity in complex solid tumor targets
12:30 pm Lunch Break & Networking
1:30 pm Discussion Time on Innovations in Fast Analytics, Automation, Emerging Technologies & Beyond
Synopsis
In this interactive session, participants will choose from multiple roundtables, each focused on a different emerging technology, such as advanced analytics, automation, high-throughput screening, or data integration. Experts and vendors will lead discussions, providing insights, case studies, and practical applications to help attendees explore solutions tailored to their specific challenges.
- Cutting-Edge Analytical Tools and Assays: Explore the latest advancements in flow cytometry, cellular assays, potency testing, and fast analytics tools for enhanced process insights
- Automation and High-Throughput Screening: Discuss process and analytical automation strategies, including high-throughput screening and data-driven decision-making
- Data Integration and Coding for Automation: Learn how data integration, AI-driven insights, and coding solutions optimize automation workflows for efficiency and scalability
2:00 pm Session Reserved for ThermoFisher
2:30 pm Afternoon Break & Networking
Ensuring Consistency & Quality Through Streamlining Comparability, Standardization, Compliance & Tech Transfer in Cell Therapy
3:00 pm COGm Analysis for an Allo Drug Product Process with a Focus on Optimizing Cost/Dose
Synopsis
- Design and cost drivers of a commercial scale allogeneic process
- Cell expansion is a key driver of cost/dose
- Path to manufacturing allogeneic therapy at <$1000/dose
- Process scaling from Phase I through Pivotal and commercial
3:30 pm Roundtable: Optimizing CDMO Partnerships for Efficient Cell Therapy Process Development, Tech Transfer & Scale-Up
Synopsis
- Bridging the Communication Gap in CDMO Collaborations: Explore the common communication challenges between CDMOs and early-stage companies, and strategies to improve alignment and efficiency, ensuring smoother technology transfer and development
- Navigating Tech Transfer to Accelerate Scale-Up: Discuss the importance of early-stage preparation to address the gaps in tech transfer, minimizing delays and costs when scaling up from research to commercial production
- Aligning Expectations with CDMO Partners to Ensure Compliance and Consistency: Examine how to manage compliance challenges, particularly around consumables and materials, while setting realistic expectations with CDMOs to maintain quality and consistency across the process development lifecycle