Implementing Potency and NG Release Assays for γδ T Cell Therapies
18 Sep 2025
Cell Therapy Manufacturing: Automation, Assays & the Allo-Auto Divide
- Assay design must reflect γδ T cell-specific mechanisms of action (e.g., cytotoxicity, cytokine release), requiring robust biological relevance and reproducibility across donors.
- Early alignment with regulatory expectations is crucial; qualification should account for γδ T cell variability, with functional thresholds tailored to non-conventional responses.
- Transferring assays across sites/labs demands strong documentation, reference standards, and training due to the complexity and donor variability of γδ T cell-based products.
