Implementing Robust Cell‑Based Characterization Strategies to De‑Risk Gene Edited iPSC Manufacturing
- Designing fit‑for‑purpose cell‑based assays to confirm correct genetic editing, functional phenotype, and product consistency early in development
- Integrating analytical characterization across molecular, vector, and cell teams to support scalable, compliant iPSC manufacturing workflows
- Lessons learned from building a core analytics function within a large pharma setting, balancing innovation, robustness, and regulatory readiness