Building Robust Manufacturing Processes for Gene Therapies

18 Jan 2023
Manufacturing Advanced Therapies Track
Charles River
Forge Biologics

11:00am Chair Introduction

Vishal Agrawal, Vice President, CMC and Process Development, Eikonoklastes 


11:05am Presentation: TBA

Alex Bloom, Senior Vice President, Technical Operations, AviadoBio


11:20am 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


11:35am 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


11:50am Presentation: eXpDNATM Plasmid Platform: Expediting pDNA Production and Supply

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


12:05pm Closing Panel with Q&A

With all session participants


Alex Bloom
Senior Vice President, Technical Operations
John Maslowski
Chief Commercial Officer
Forge Biologics
Ramin Baghirzade
Senior Director, Gene Therapy
Charles River
Scott Bertch
Executive Director, Clinical Site Head
Tenaya Therapeutics
Vishal Agrawal
Vice President, CMC and Process Development
Eikonoklastes Therapeutics