Roundtable Discussion: Navigating the Chicken & Egg Dilemma – Ensuring Analytical Methods Detect Product Instability in Cell Therapy Stability Studies
Time: 3:30 pm
day: Conference Day One
Details:
- Explore the challenge of correlating traditional stability measurements, such as vector titer, with functional potency in cell therapy vectors.
- Discuss the importance of functional potency as a critical quality attribute and the need for innovative approaches to assess it accurately over time
- Examine alternative study designs for stability indicating studies, including deliberately inducing stress on vectors to evaluate their functionality under suboptimal conditions.
- Discuss the advantages and limitations of these approaches in providing insights into the long-term stability and efficacy of cell therapy vectors
- Highlight the role of predictive analytics and computational modeling in predicting the stability and functional potency of cell therapy vectors.
- Explore how advanced data analytics techniques can aid in optimising storage conditions, minimising degradation, and ensuring consistent vector performance throughout manufacturing and storage processes
