Presentation: In Vitro Relative Potency Assays for Commercialization of Gene Therapy Products

Presentation:
In Vitro Relative Potency Assays for Commercialization of Gene Therapy Products

Originally Presented:
Monday, April 29, 2019
ASGCT Annual Meeting
Washington, DC

Presenter: Karen Doucette, MBA
Director of Operations, ACF Bioservices

What you will learn:

• Considerations for in vitro potency assay development for gene therapy products with complex MOA(s)
• Case studies demonstrating expression and functional activity in genetically modified cell lines
• Long term considerations for the potency assay approach – R&D through commercialization and lot release

Due to popular demand, this presentation is an expanded version of Karen’s ASGCT presentation, providing a more comprehensive look at the approach for potency assay development and validation, along with case studies detailing tools, technologies, and challenges.