Why Is It Important to Measure Potency?
The last decade has seen a rapid development in cell and gene therapies (CGT), which now offer promising solutions for diseases that could not be adequately treated by traditional pharmaceuticals. Potency assays that measure the product-specific biological activity in a disease-relevant system are required by regulatory agencies to grant approval to CGT products. These potency assays provide essential information about efficacy, safety, and activity. Developing these assays has unique challenges, from difficult samples to measuring transgene delivery and validating mechanisms of action.
Explore the common challenges, analytical tools, and importance of selecting appropriate assays for the development of potency assays for cell and gene therapy products including:
- The challenges of assay development
- Selection criteria for analytical tools
- Tips for developing potency assays for cell and gene therapy products
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