Considerations in early stage process design for cellular and gene therapy products
15 Apr 2025
C & G Bioprocessing
- What are some of the critical considerations while designing processes for early stage CGT products?
- How to think through phase appropriateness of process development, speed vs. process robustness for early stage CGT products
- Is it too early to think about critical quality attributes (CQAs) and identify Critical Process Parameters (CPPs) at an early stage for cell and gene therapy processes?
- How do you manage product complexity and variability that is inherent to autologous cell therapy products
- Comparability plans during process changes as you scale up?
