Establishing a Robust Stability Program for Autologous Cell Therapy Products
Time: 2:00 pm
day: Conference Day One
Details:
- Determine key stability parameters such as cell viability, potency, identity, and purity to establish the stability profile of autologous cell therapy products
- Develop comprehensive stability study protocols, including storage conditions, sampling schedules, and analytical methods, to assess the stability of cell therapy products over time
- Execute stability testing according to regulatory guidelines, ensuring compliance and generating data to support product shelf-life determination and regulatory submissions
