Session VII – Analytical Development Case Studies & Closing Remarks

Cell and gene therapy products represent a complex and evolving class of products where analytical development and characterization methods are not universally established and yet are critical to product development. One of the biggest challenges for cell and gene therapy products is establishing an appropriate analytical strategy to support product manufacture, release, stability, comparability, and characterization across the different stages of product development. Frequently these products are under accelerated development and it is therefore even more critical to establish comprehensive analytics early on. This session will highlight some of the existing analytical challenges through analytical development case studies and provide guidance on development of an appropriate strategy to help overcome these issues.

Question for Discussion:
1. What recommendations would you suggest in accelerating the development and validation of a new method and demonstrating its comparability or superiority to existing methods?
2. Since analytical equipment and techniques continuously evolve especially for cell and gene therapies, what additional considerations should a Sponsor do to mitigate the analytical method development challenges throughout the lifecycle of these type of products (ie., pre-approval and post-approval)?
3. How mature should the analytical panel be at Phase I? Does product type and indication matter?