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
9:30 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
10:00 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.
11:00 am Phase-appropriate methods to demonstrate process comparability in C&G therapies
Synopsis
- Study design and reducing noise due to critical raw materials through blocked study design
- Statistical approaches used to establish comparability
- Risk assessment, regulatory challenges, and final package assembly
11:30 am From Bench to Batch: Operational Readiness for ATMPs in the New Regulatory Era
Synopsis
- Examine how the EMA’s 2025 Guidance on ATMPs and the FDA’s June 2025 Roundtable are reshaping expectations across both research and GMP environments in cell and gene therapy
- Explore practical strategies for aligning with evolving regulatory demands, including structured data capture, end-to-end traceability, bi-directional cell and reagent lineage tracking, electronic batch records, and real-time quality oversight
- Gain a roadmap for regulatory alignment and future-proofing ATMP operations— whether building autologous therapies or scaling allogeneic platforms
11:45 am Industry 5.0 manufacturing of cell therapies, CAR T case study, utilizing real-time data-based manufacturing, machine learning, and AI
Synopsis
- Industry 5.0, bringing humans back to the center, promoting collaboration between advanced technologies and human intelligence.
- Case studies of live data-driven CAR T processes, metabolic learnings.
- Optimizing and shortening process development by real-time data and control.
- Real-time predictions and out-of-spec minimization utilizing metabolic sensing.
12:15 pm Lunch Break & Networking
1:15 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
1:15 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
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
2:00 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.
2:30 pm Afternoon Break & Poster Session
3:30 pm Round Table: Achieving Consistency Amid Biological Variability: Tackling Cell Sourcing & Raw Material Challenges”
Synopsis
- Identify Root Causes of Variability: Analyze real-world donor and raw material case studies to uncover sources of inconsistency in expansion, potency, and phenotype.
- Mitigation Through Process & Quality Controls: Share peer strategies to manage risks— lot qualification, supplier oversight, in-process testing, and acceptance criteria.
- Collaborative Problem-Solving: Engage in small group exercises to troubleshoot scenarios and generate practical insights applicable across platforms.
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