Sessions

Achieving Operational Excellence in Cell and Gene Therapy Manufacturing
End-To-End Manufacturing and Downstream Bioprocessing
Upstream Bioprocessing Optimisation and Support for Early Development
Reducing Timelines with Innovative Scale Up and Scale Out Technologies
Key Considerations in Cell and Gene Therapy Manufacturing – CMC, Process and Regulatory

Achieving Operational Excellence in Cell and Gene Therapy Manufacturing

26 Jan 2022
11:00
Miami Convention Center, Miami, FL
SPONSORED BY
Cellares
TreeFrog Therapeutics
Cell and Gene Therapy Catapult

11:00 Chairperson’s Opening
Sharon Brownlow, Chief Business Officer, Cell and Gene Therapy Catapult

11:05 Operational Excellence in Cell Therapy Manufacturing – Simple & Effective Tools that Drive Manufacturing Success

  • The art of Opex – framework and tools for success
  • Connecting Opex strategies to your business and operating models
  • Executing on Opex in Cell Therapy Manufacturing

Tara Crnkovich, Senior Director, Site Lead – Clinical Biologics & Cell Therapy Manufacturing, AstraZeneca

11:20 Automation Beyond the Buzzword

  • How can we expand beyond disparate technologies?
  • What is our potential once we truly automate cell therapy manufacturing?

Fabian Gerlinghaus, Co-Founder and Chief Executive Officer, Cellares

11:35 New Microfluidic Approaches To Perform Cell Transfections for Clinical Scale Cell Therapy Manufacturing

  • Overview of microfluidic approaches to cell engineering and benefits to uniformity in cell processing
  • Show how high mechanical forces acting on very short timescales can enable new mechanisms for delivery of gene editing cargo to create therapeutic cell products
  • Highlight 2 examples of cell therapy workflows for CAR T processing and regenerative medicine.
  • Describe how this technology can enable new capabilities in cell engineering workflows and manufacturing

Todd Sulchek, Co-Founder, CellFE

11:50 From 50 Million to 15 Billion Human iPS Cells Within A Week: Highly-Reproducible Exponential iPS Expansion in 10l Bioreactors with Maintenance of Cell Quality

Using proprietary C-StemTM technology, TreeFrog Therapeutics announced in 2021 the production of single batches of 15 billion human induced pluripotent stem cells (hiPSC) in 10L bioreactors with an unprecedented expansion factor of 276-fold per week. Biomimetic C-StemTM technology introduces:

    • A highly scalable manufacturing process, allowing for the mass-production of cell therapies based on induced pluripotent stem cells (iPSC)
    • A new quality standard for iPSC-derived cell therapy products, with preservation of genomic integrity at scale
    • Ready-to-transplant hiPSC-derived 3D microtissues, for faster time to effect and improved safety

Kevin Alessandri, Co-Founder, Chief Technical Officer and Vice President USA, TreeFrog Therapeutics

12:05 Speaker Q&A & Panel Discussion: How Do We Certify Operational Excellence For CGT?

Speakers

Sharon Brownlow
Chief Business Officer
Cell and Gene Therapy Catapult
Tara Crnkovich
Senior Director, Site Lead – Clinical Biologics & Cell Therapy Manufacturing
AstraZeneca
Fabian Gerlinghaus
Co-Founder and Chief Executive Officer
Cellares
Todd Sulchek
Co-Founder
CellFe
Kevin Alessandri
Co-Founder, Chief Technical Officer and Vice President USA
TreeFrog Therapeutics