Conference Day Two
Thursday, July 17

8:30 am Check-In & Coffee

9:25 am Chair’s Opening Remarks

  • Alex Druz Director Cell Process Development, Arcellx

Strategies for Success Through Overcoming Barriers to Scalability & Commercialization

9:30 am Manufacturing CAR-T Cells Using Whole Blood Collection

  • Yan Li Senior Director - Process Development, Manufacturing Science & Technology, Cabaletta Bio

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 Can we introduce four cell therapy manufacturing developments in under 30 minutes? Let’s find out.

  • Evan zynda Sr. Scientist, R&D Strategic Alliances, Thermo Fisher Scientific Inc

Synopsis

  • Overcoming challenges in safety and cost to broaden the applicability of cell therapies
  • Innovative processes and products to aid in isolation and activation of cells
  • Fit for purpose tools to streamline the production of high quantity and high quality cellular outputs

10:30 am Morning Break & Networking

11:30 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

12:00 pm Regulatory CMC Considerations for Cell Therapy Product development

  • Seraphin Kuate Director Global CMC Regulatory, CAR T Cell Therapy, Bristol Myers Squibb

Synopsis

  • Key CMC challenges across early and late-stage cell therapy development
  • Strategies for managing comparability, potency, and process control
  • Regulatory alignment to support global submissions and commercialization

12:30 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

1:00 pm Lunch Break & Networking

2:00 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

Ensuring Consistency & Quality Through Streamlining Comparability, Standardization, Compliance & Tech Transfer in Cell Therapy

2:45 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

3:15 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

4:00 pm Chair’s Closing Remarks

4:05 pm End of the 4th Process Development for Cell Therapies Summit