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A NIST–FDA Joint Workshop
This workshop aims to support ongoing pre-standardization and standardization efforts for analytical methods used in cell therapy characterization and testing. Documentary standards are a critical aspect of the supporting infrastructure for advanced therapies. They can promote innovation and translation, help to secure supply chain and other infrastructure, and help to streamline regulatory review and reduce cost and time to market. Recent FDA guidance has established a standards recognition program for regenerative medicine therapies (SRP-RMT) and ongoing national and international pre-standardization and standardization efforts continue to drive standards development. Here we will discuss standardization efforts for several key analytical methods for cell therapy product characterization and testing including cell viability assays, cell activity assays, and assays related to cell therapy product safety including residual cells and sterility testing. We will conclude with a panel discussion on key considerations for cell therapy analytical method standardization.
| Day | Time | Session |
|---|---|---|
Wednesday, | 9:00 am – 9:30 am | Setting the Stage: Cell Therapy Characterization and Testing Standards Overview |
| 9:30 am – 9:50 am | FDA Standards Recognition Program and Implications for CGT |
| 9:50 am – 10:10 am | Standards Development and Coordination |
| 10:10 am – 10:30 am | Sterility Testing of Cell Therapy Products |
| 10:30 am – 11:00 am | Coffee break |
| 11:00 am – 12:30 pm | Cell Viability Assay Standardization Efforts |
| 12:30 pm – 1:30 pm | Lunch |
Wednesday, | 1:30 pm – 2:30 pm | Cell Killing Assay Standardization Efforts |
| 2:30 pm – 3:30 pm | Characterization of iPSC-Based Cell Therapy Products |
| 3:30 pm – 4:00 pm | Coffee break |
| 3:30 pm – 4:45 pm | Panel Discussion |
| 4:45 pm – 5:00 pm | Wrap-Up |