Agenda

9:30am Registration & Refreshments

10:30 am Opening Remarks

10:40 am Comparing & Contrasting CGT Production Systems

Synopsis

  • Are all CGT production systems created equal? What are the similarities of each and where are the differences in each?
  • Where is the waste in each approach and how can the waste be eliminated?
  • What are the benefits unique to modular manufacturing?
  • What should developers look for as they advance to/through the clinic towards IND/BLA from a CMC strategy perspective?

11:20 am Panel Discussion: Why the Time is Now for LEAN Cell & Gene to Solve the Manufacturing Crisis

Synopsis

  • What is holding cell and gene therapy developers back from innovating their manufacturing approach?
  • Is the need to make therapies available more quickly safely and more cost effectively more important than scientific innovation?
  • What are the solutions developers can take away today to adopt a LEAN mindset, and achieve more with less

12:00 pm Catered Lunch

1:00 pm Real-Time Monitoring & Lean Optimization in Cell Therapy with SMART PAT Technologies

  • Nigel Reuel President & Founder, Skroot Laboratory Inc.

Synopsis

  • How do the SMART sensors work and how can they prevent defective product?
  • What other LEAN functions can this PAT tech serve?

1:30 pm Moving Beyond Mouse Models & Reducing Waste with 3D Tumor Organoids

  • Katie McKenna Assistant Professor, Center for Cell & Gene Therapy, Baylor College of Medicine

Synopsis

  • Addressing limitations of mouse models by exploring why they often fail to predict clinical outcomes and how this drives the FDA's push for human-relevant alternatives
  • Unpacking current 3D organoid culture methods to highlight challenges with scalability, reproducibility, and material waste
  • Leveraging G-Rex for organoid culture to support culture to support long-term viability and improve model fidelity

2:00 pm Automating Potency Assays with Ella to Improve Consistency & Throughput

  • Ramya Tunuguntla Director - Process Development, Stanford's Laboratory of Cell and Gene Medicine, CCT, Stanford University

Synopsis

  • Traditional potency assays often rely on manual workflows that are time-consuming, variable, and difficult to scale
  • Why automation using platforms like Ella can help address common issues such as variability and throughput without overhauling the assay itself

2:30 pm Reducing Variability & Increasing Throughput with Automated Flow Cytometry Systems

Synopsis

  • A look at how flow cytometry is typically performed today, including manual gating, analyst variability, and batch-to-batch inconsistency
  • What's been learned from implementing automated flow systems, including benefits around throughput, standardization, and assay transfer

3:00 pm Networking Break

3:30 pm Enhancing TCR-T Cell Manufacturing with Cytokine Innovation & G-Rex Process Optimization

  • Eric Tran Research Associate, Zymo Research

Synopsis

  • Continuous improvement of a legacy G-Rex process
  • Incorporating novel cytokines in the culture to increase product quality
  • Practical insights to increase throughput capacity for treating larger patient populations

4:00 pm Improving TIL Quality & Manufacturing Through Smart Engineering & Scalable Process Design

  • Beau Webber Associate Professor - Pediatric Hematology & Oncology, University of Minnesota - Twin Cities

Synopsis

  • Improving drug product quality through clever genome engineering
  • Optimizing TIL manufacturing for industrial production
  • Overcoming the remaining barriers

4:30 pm Improving on CAR-T Cell Manufacturing

  • Ying Xiong Director - Scientific Collaboration & Cell Therapy, Caring Cross

Synopsis

  • How does decentralized manufacturing solve bottlenecks in CAR-T?
  • What are common bottlenecks that all manufacturing approaches share?
  • Why is throughput still a consideration even in a point of care/decentralized model?

5:00 pm Closing Remarks

5:10 pm Drinks Reception

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