Developing Successful Potency Assays to Determine Activity of Your Cell Therapy Product
Time: 1:00 pm - 3:00 pm
day: Pre-Conference Workshop Day - Workshop D
There is no single test that can adequately measure the product attributes that predict clinical efficacy; therefore, developing a successful potency assay is notoriously hard to accomplish. Additionally, to successfully develop a potency assay, many challenges must be overcome, including the inherent variability of starting materials, limited lot size and material for testing, limited stability, lack of appropriate reference standards, complex mechanism of action(s) and more.
- Learn to develop a potency assay matrix that involves evaluating two or more mechanisms of action
- Address potency not only for CAR-T, but for gamma delta T cells and other cell therapy drug products that possess different mechanisms of actions
- Understand how to set up controls and a reference standard, without a golden standard
- Prepare for BLA submission by exploring the best ways to validate both quantitative and qualitative potency assays