Advancing Differentiation Monitoring to Strengthen Process Understanding in Cell Therapy Manufacturing
- Expanding monitoring from final identity and purity assays to in‑process sampling and characterization to better understand cell differentiation pathways and off‑target populations throughout manufacturing
- Addressing the challenges of monitoring a “living drug” by identifying meaningful process parameters (e.g. metabolites, cell viability, yield) and correlating them to critical quality attributes and product performance
- Using in‑process data to enhance insight into differentiation dynamics, impurity clearance, and process variability – laying the foundation for improved control, reduced risk, and stronger regulatory confidence