Enabling assay robustness in cell and gene therapy design and manufacturing
04 May 2026
Gene Therapy Manufacturing
- How can assay design be optimized to ensure robust performance across the variability inherent in cell and gene therapies?
- What sources of biological and process variability most impact assay reliability, and how can they be controlled?
- Which critical quality attributes (CQAs) should assays consistently measure to support manufacturing robustness?
- How can assays be standardized or adapted to remain reliable across different manufacturing scales and platforms?
- What role do validation strategies and continuous monitoring play in maintaining assay robustness over time?
