Parallel Session 7: Unique Challenges of Stability Testing for Cell and Gene Therapy Products

Cell and Gene Therapy programs are progressing from early academic settings to commercial manufacturing at increasingly faster pace and in greater numbers. These therapies are complex, difficult to manufacture in large quantities, and involve many bespoke technologies to make, test and release. Stability of these products is important to determine, and demonstrate the quality, safety and efficacy throughout the product shelf life which can vary widely between cell therapy products (e.g., autologous T cell products which are dosed immediately) and some gene therapies (e.g., AAV or LVV products that can be manufactured for inventory and require longer shelf storage stability). 




In this session, we will explore challenges in the design, execution and interpretation of stability studies for Cell and Gene therapy products. Additional topics include addressing short shelf life, in-use stability, product heterogeneity, lack of standardized protocols and harmonized health authority requirements and expectations and challenges with sample collection and storage.




Session Speakers:




Stability Challenges for Gene Therapy (GTx) Programs

Bingli Yan, Pfizer Inc.




Minimizing Volume Requirements for Stability Studies of Viral Vector-Based Gene Therapy Products

Ying Xu, Sanofi




Critical Quality Attributes, Stability-Indicating Test Methods and Cell-based Products: Untangling the Gordian Knot 

Don Fink, Dark Horse Consulting Group, Inc.




Additional Panelists:




Julia O'Neill, Direxa Consulting