Building Robust Manufacturing Processes for Gene Therapies

18 Jan 2023
Manufacturing Advanced Therapies Track
Charles River
Forge Biologics

03:30pm Chair Introduction

David Chang, Chief Executive Officer, WuXi Advanced Therapies & OXGENE


03:35pm Presentation: Selecting the Right Gene Therapy CMC Strategy

  • Key learnings in gene therapy manufacturing
  • Review of internal, external and hybrid CMC models
  • An overview of the AviadoBio platform

Alex Bloom, Senior Vice President, Technical Operations, AviadoBio


03:50pm Presentation: Addressing the ‘Capacity Crunch’ with a Scalable Platform Process Approach

  • The battle between time and cost with a custom vs. a platform process
  • How a platform process accelerates scale-up and can de-risk development challenges
  • Regulatory advantages when leveraging a platform DMF
    • Applying Forge’s proprietary tools, advanced technology, and full suite of in-house services to benefit client programs

John Maslowski, Chief Commercial Officer, Forge Biologics


04:05pm Presentation: Challenges, Key Considerations and Benefits for Taking Manufacturing In-House

  • As industry strives to develop more precise, curative medicines using advanced approaches such as gene and cell therapies, the stakes for getting manufacturing right have increased exponentially. In his presentation, Scott Bertch will highlight:
    • The strategic advantages of establishing manufacturing capabilities for genetic medicines early in a biotech company’s journey
    • Key considerations to account for when building out manufacturing capabilities.
    • Highlights from Tenaya’s own Genetic Medicine Manufacturing Center build-out

Scott Bertch, Executive Director, Clinical Site Head, Tenaya Therapeutics


04:20pm Presentation: eXpDNATM Plasmid Platform: Expediting pDNA Production and Supply

Ramin Baghirzade, Senior Director, Gene Therapy, Charles River Laboratories


04:35pm Closing Panel with Q&A

With all session participants


Alex Bloom
Chief Technology Officer
Samarendra Mohanty
Co-Founder and President
Nanoscope Therapeutics
John Maslowski
Chief Commercial Officer
Forge Biologics
Ramin Baghirzade
Senior Director, Gene Therapy
Charles River
Scott Bertch
Executive Director, Clinical Site Head
Tenaya Therapeutics
David Chang
Chief Executive Officer
WuXi Advanced Therapies