Exploring Best Practices for Demonstrating Product & Process Comparability
Time: 1:00 pm
day: Pre-Conference Workshop Day
Details:
During the clinical development of a cell-based therapy product, changes are often necessary to the manufacturing process to improve the performance and quality of the final product. However, to successfully implement a process change, we must demonstrate the comparability of the pre- and post-process, and the final product.
Join to:
- Discuss changes that commonly occur to the process, facilities, raw materials, and analytical methods
- Understand key elements of an effective comparability study (1) the level of risk by type of process change, (2) stepwise reduction of residual risk, and (3) a risk-based effort by stage of clinical development
- Explore best practices for effective demonstration of comparability
