Improving Gene Therapy Safety with High-Sensitivity Impurity Profiling that Identifies Hidden Contaminants Across the Process
- Pinpointing where HCPs, residual DNA, and process-related contaminants accumulate across upstream, downstream, and final formulation to give teams a proactive risk profile
- Evaluating when LC-MS, DIA-MS, ddPCR and immunoassays complement each other to ensure no single assay misses critical contaminants
- Linking impurity patterns to potency drift, vector quality, and safety signals