7:30 am Check-In & Coffee
8:25 am Chair’s Opening Remarks
8:30 am Panel Discussion: The Process Development Playbook — Insights from Industry Veterans & Commercialized Products
Synopsis
Behind the Scenes of Successful Process Scaling: Key strategies and lessons learned from scaling processes while maintaining quality and efficiency
- Navigating Common Roadblocks in Process Development: Practical tips for overcoming bottlenecks, variability, and resource challenges
- The Future of Cell Therapy Development — What’s Next and How to Stay Ahead: Emerging technologies and trends shaping the future of process development
Harnessing Innovation & Technology for Future-Forward Manufacturing to Achieve Affordable Cell Therapies Without Compromise
9:15 am Optimizing CQAs for Scalable, Cost-Effective Cell Therapy Manufacturing
Synopsis
- Defining CQAs for Consistency: Early identification of Critical Quality Attributes ensures product safety, consistency, and efficacy throughout production
- High-Throughput Analytics: Tools like flow cytometry and mass cytometry enable simultaneous CQA measurements, improving real-time monitoring and speeding up decision-making
- Streamlining Control Strategies: Effective control strategies based on CQAs ensure predictable, scalable manufacturing, supporting cost efficiency as production scales up
9:45 am Advances in T Cell Therapy Manufacture from FUJIFILM Irvine Scientific & Terumo Blood & Cell Technologies
Synopsis
- FUJIFILM Irvine Scientific and Terumo Blood and Cell Technologies have recently joined forces to define optimal T cell expansion
- Optimize settings in the hollow fiber Quantum Flex Cell Expansion System, while efficiently connecting media and raw materials
- Maintain robust T cell expansion levels and optimal phenotype by streamlining operations in a closed system
10:15 am Morning Break & Speed Networking
Synopsis
As this community re-unites for the 4th time, this session will provide valuable networking time with your peers, enabling you to forge new and lasting connections.
11:15 am Achieving End-to-End Process Control & Analytics Integration with Automation
Synopsis
- End-to-End Automation in Cell Therapy: Exploring how automation streamlines the entire manufacturing process, ensuring consistency, scalability, and reducing human error
- Automating Data Analytics and Batch Records: Integrating automated systems for real-time data collection and reporting, enhancing process efficiency and maintaining regulatory compliance
- Overcoming Implementation Challenges: Addressing integration issues, regulatory hurdles, and the transition to fully automated workflows in cell therapy production
11:45 am Session Reserved for Miltenyi
12:15 pm Roundtable Discussion: Delving into Ultra-Fast Manufacturing with 24-48 Hour Autologous Cell Therapy Production
Synopsis
- Analytical Challenges: How can potency assays and transgene expression testing be accelerated for rapid
- turnaround?
- Gene Delivery Innovations: Exploring alternatives to viral vectors, such as CRISPR or AAV knock-ins, to enable faster gene expression
- Real-World Implementations
- Donor Variability: Addressing the impact of donor-to-donor variability on cell quality and consistency in ultra-fast production timelines
12:15 pm Roundtable Discussion: Precision Manufacturing in Allogeneic Cell Therapy by Overcoming Donor Variability, Gene Editing & Scale-Up Challenges
Synopsis
- Standardizing Donor Material: Tackling donor-to-donor variability and setting clear criteria for starting material quality
- Optimizing Gene Editing Strategies: Managing complex edits for immune evasion, persistence, and maintaining product consistency across multiple modifications
- Scaling Up Production and Fill-Finish: Addressing challenges in bioreactor selection, large-scale expansion, and efficient fill-finish solutions for high-volume therapies
12:45 pm Lunch Break & Networking
1:45 pm Harnessing AI for Streamlined Process Development, Cutting Costs & Accelerating Time to Market for Cell Therapies
Synopsis
- Accelerating Data Integration and Automation: How AI can integrate data from multiple systems, automate data entry into electronic lab notebooks, and offer faster turnarounds with real-time analysis for more efficient process development
- AI-Driven Real-Time Insights and Predictive Analysis: Exploring AI’s ability to deliver predictive insights and perform correlative analysis on key process data, such as cell viability, reducing manual analysis and enhancing decision-making
Ensuring Consistency by Overcoming Challenges in Cell Sourcing & Raw Material Control
2:15 pm Characterization of Neutrophils in Apheresis Starting Material & Their Impact on CAR-T Manufacturing
Synopsis
- Discussion of elevated neutrophil levels observed in apheresis
- Neutrophil impact on cryopreservation and T cell activation
- Unique phenotypic characteristics of contaminating neutrophils in apheresis compared to healthy donor circulating neutrophils
2:45 pm Revolutionizing Immunotherapy: Ultra-Fast 30-Hour CAR T Cell Manufacturing with the SWIFT CAR T Platform for Next-Generation Autologous Therapy
Synopsis
- Ultra-Fast Manufacturing: The SWIFT CAR T platform reduces production time from 12–14 days to 30 hours, accelerating patient access to life-saving therapy.
- Superior T Cell Fitness: It preserves stemness, memory phenotypes, and enhances expansion, potency, and persistence, boosting antitumor efficacy.
- Efficiency & Accessibility: A cost-effective, low-toxicity, and adaptable approach that minimizes contamination risks, speeds up treatment, and sets a new immunotherapy benchmark with novel fully human CAR.
3:15 pm Afternoon Break & Poster Session
4:15 pm Optimizing Harvest & Cryopreservation of Cell Therapy Drug Product
Synopsis
- Enhancing harvest procedures for streamlined manufacturing, maximized yield, and preservation of clinical drug product integrity for patient use
- Refining harvest protocols for optimal efficiency
- Strategic considerations for drug product presentation
- Tailoring cryopreservation profiles for enhanced outcomes
- Post-thaw analytics: Evaluating the impact of optimized procedures on drug product characteristics
4:45 pm Optimizing Apheresis Logistics: Frozen vs. Fresh – A Critical Evaluation for Cell Therapy Manufacturing
Synopsis
- Logistical Considerations: Examining the operational challenges and complexities involved in transporting and storing frozen versus fresh apheresis materials
- Quality Control & Processing Impact: How the choice between frozen and fresh apheresis impacts cell viability, processing efficiency, and product quality
- Leveraging Benefits for Scalable Manufacturing: Identifying the advantages and limitations of both options to determine the most effective strategy for large-scale, reproducible cell therapy production