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.