Challenges Associated with Measuring Potency in Cell and Gene Therapy Products
While no single test can validate the biological activity and predict the protential therapeutic effect of a product, different assays can be used to demonstrate potency throughout the manufacturing process as well as following market approval.
Explore the current state of cell and gene therapy and discover the key challenges associated with developing potency assays during product developmental, including:
- Product approval requirements in cell and gene therapy
- Importance of consistently demonstrating potency throughout product development
- What you need to consider when developing potency assays
- How certain tools can help address key challenges associated with measuring potency
Access the Article
Share a little information with us to access the entire article now.
View ArticleContent you'll also find interesting
Recommended Features
Measuring Potency of Cell and Gene Therapy Products
Discover different delivery systems used for advancing gene therapy, including viral and non-viral vectors, and the benefits and challenges of each approach.
From Concept to Cure: Using AAV in Gene Therapy
Use this guide to learn about AAV vector challenges, AAV characterization, and addressing developmental hurdles of using vectors in gene therapy.
The Role of Droplet Digital™ PCR in Developing Safe and Effective AAV-Based Gene Therapies
Learn how ddPCR technology offers the accuracy to quantify AAV viral titers to support many aspects of quality control for AAV-based gene therapy development.
