9:00 am Chair’s Opening Remarks

Developing iPSC Differentiation to Efficiently Create the Desired Target Cell Type

9:10 am Accelerating the Manufacture of Neural Cell Types from Human Pluripotent Stem Cells

  • James Dutton Associate Professor, Stem Cell Institute, University of Minnesota

Synopsis

  • Improving the control of neural induction and patterning increases the speed and reproducibility of iPSC-neuron manufacture
  • Implications of accelerated iPSC-neuron differentiation for product manufacture
  • Application of automation to stem cell derived neuron production

9:40 am A Phase I/IIa Trial to Test Safety and Feasibility of iPSC-Derived RPE Patch in Macular Degeneration Patients

Synopsis

  • Autologous iPSC manufacturing process
  • QC for clinical-grade iPSC
  • Efficient RPE differentiation process for improving manufacturing robustness

10:10 am Leveraging a 3D-Organoid Co-Culture System to Effectively Differentiate iPSCs

  • Daniel Wang Assistant Research Professor, City of Hope

Synopsis

  • 3D-organoid coculture system supports differentiation of CAR and iPSCs into highly functional CAR-T cells with conventional T cell phenotypes
  • Utilizing feeder cells to optimize iPSC-directed differentiation
  • Incorporating approaches to enhance anti-tumor potency of iPSC-derived CAR-T cells

10:40 am Novel Cell Separation Technology Using Magnetic Agarose-Based Beads: Proof of Concept

Synopsis

  • Scalable from μL – multi L culture media/cells
  • Over 90% sorting efficiency
  • High magnetization – quick mobility

10:50 am
Morning Refreshment Break & Networking

11:45 am Engineering iPSCs with Synthetic Receptors to Drive Differentiation Compatible with Scale-Up

Synopsis

  • By genetically engineering iPSCs to express a synthetic cytokine receptor, iPSCs can more efficiently be differentiated into functional, persistent immune cell types
  • Differentiation can be performed in suspension, making it compatible with efficient scale-up production
  • This overall approach may be used in a manufacturing setting to drive high purity immune cell production

Tailoring Analytics to Cater Specifically to iPSC Manufacturing

12:15 pm Roundtable Discussion Session


A

Overcoming Potency Testing and Cell Characterization Hurdles

  • Discussing potency indicators and genetic influences in different cell types to aid development of
    cell line-specific potency testing
  • Exploring methods to expand the cell marker repertoire and utilize different cell markers in specific
    cell lines


B

Minimizing Sampling Intervention

  • Reviewing ways to ensure culture samples are well mixed and discussing best
    culture-tracking approaches
  • How can we utilize automation and AI to reduce the need for sampling intervention?

1:15 pm
Lunch Break and Networking

Incorporating Effective Gene Editing into Manufacture to Turbocharge Engineered iPSC Therapies

2:30 pm Manufacture of Gene-Edited iPSC-Derived NK Cells for Solid Tumor Immunotherapy

Synopsis

  • What are the important features for product-centric allogeneic immunotherapy, and how can we create this using iPSC?
  • Lessons learned and implementation of gene-editing for developing master cell banks, and iNK differentiation
  • Product development: translational studies toward the clinic with CTH-401

Revolutionizing Cryopreservation to Unlock Superior iPSC Products

3:00 pm Understanding Cryopreservation throughout the iPSC Differentiation and Manufacturing Process

  • Shiv Mistry Senior Associate Engineer, Century Therapeutics

Synopsis

  • Clarifying the need for cryopreservation at various steps of iPSC manufacture
  • Development of cryopreservation unit operations to ensure a high level of consistency for allogeneic cell therapies
  • Optimizing formulation of drug product based on post thaw quality attributes, clinical tolerance, and process capabilities

3:30 pm Close of Conference Day Two