Workshop C: Building a Robust Control Strategy in Early-Phase Development of Cell Therapies
Time: 1:00 pm
day: Workshop C
Details:
In early-phase development, managing variability in starting materials, such as donor cells and raw materials, is crucial for ensuring consistent and reproducible cell therapy products. This session will explore strategies for establishing control measures that address these challenges and ensure clinical trial success.
- Establishing Protocols for Starting Material Variability: Developing strategies for sourcing both autologous and allogeneic cells to ensure consistent quality
- Early-Phase Analytical Strategies: Employing robust analytical methods to monitor product consistency throughout early development
- Ensuring Reproducibility Across Batches: Addressing challenges in material variability and ensuring a consistent product for clinical trials
