Advancing Process Validation in Gene Therapy: Best Practices for Scale-Down Models & Characterization
24 Jun 2025
Gene Therapy Manufacturing
- What are the biggest challenges in developing a robust process characterization strategy for gene therapy manufacturing?
- What risk assessment approaches have been most effective in identifying sources of process variability in gene therapy manufacturing?
- What are the key considerations when designing scale-down models for gene therapy processes?
- How do you ensure that a scale-down model is representative of large-scale manufacturing? Experiments and Statistics
- What are the best strategies for using analytical data to support scale-down model qualification and validation
- How can analytics help address regulatory concerns related to batch-to-batch variability in gene therapy products?
- Can we leverage AI and if so how can we leverage AI for real-time process monitoring and predictive analytics in gene therapy?
