Building Better Quality Products: Quality Control and Assurance

19 Jan 2023
Manufacturing Advanced Therapies Track

11:00am Chair Introduction

Cynthia Pussinen, Chief Technology Officer, Spark Therapeutics


11:05am Presentation: Developing allogeneic CAR-T cell products from iPSCs

  • Notch is focused on small footprint, suspension-based manufacturing solutions for iPSC-derived T cells
  • Products require early generation of well-characterized and commercially compatible GMP iPSC lines, gene editing and manufacturing processes
  • Uniform and well characterized products will meet CMC regulatory standards and reduce clinical variability

Emily Titus, Senior Vice President, Technical Operations, Notch Therapeutics


11:20am Presentation: Implementing A 1-hour Mycoplasma Test for Immune-Effector Cells

  • Addressing the current challenges faced in product release
  • Benefits of an ultra-rapid and simplified assay to face scarcity of highly skilled workforce
  • Validation approach for multiple products

Zankar Desai, Assistant Technical Director, Cell Therapy Testing Lab, Dana-Farber Cancer Institute


11:35am Presentation: Incorporation of QbD Early Into Development

  • Importance of Assay Validation:
    • Phase appropriate advancement of assay validation
    • The Phases of Development
    • Case Study: Cell Count Qualification Across Multiple Devices
    • Continual Verification

Donna Rill, Chief Technical Officer, Triumvira Immunologics


11:50am Presentation: Garbage in, Garbage Out… Importance of QC Testing in Cell Therapy Manufacturing

  • Addressing potential sources of variability in starting materials
  • Utilizing flow cytometry in-process to make real-time actionable decisions with your drug product
  • Simplifying QC release w/ automation to improve reproducibility
  • How automation can help address the talent shortage in QC

Matt Li, Director, Cell Therapy CMC, Tome Biosciences


Pete Cotter, Associate Director, Analytical Development, Verve Therapeutics


12:05pm Closing Panel with Q&A

With all session participants


Cynthia Pussinen
Former Chief Technical Officer
Spark Therapeutics
Donna Rill
Chief Technical Officer
Triumvira Immunologics
Matthew Li
Director, Cell Therapy CMC
Tome Biosciences
Pete Cotter
Associate Director, Analytical Development
Verve Therapeutics
Zankar Desai
Assistant Technical Director, Cell Therapy Testing Lab
Dana-Farber Cancer Institute