Session Chairs: Svetlana Bergelson, Biogen and Seshu Tyagarajan, Candel Therapeutics

Analytical characterization is essential for developing cell and gene therapy (CGT) products. It guides process development, determines storage conditions, assesses stability, and ultimately supports product release for patient use. The complexity of CGT products necessitates a wide range of quality assessment methods, often resulting in multiple assays for release and stability testing.

This session will focus on strategies to optimize these testing panels by leveraging different approaches to assess Critical Quality Attributes (CQAs). One strategy involves adopting new technologies to develop superior, validatable methods that correlate with existing orthogonal assays. Another approach uses a matrix of methods for enhanced product characterization, allowing a focus on the most suitable methods for advancing the product. For autologous cell therapies, maximizing sampling efficiency, minimizing sample volume, and reducing testing turnaround time are critical considerations for release testing panels.

As the CGT field expands, embracing these varied approaches will be crucial for efficiently delivering these transformative therapies to patients.

Session Speakers:

Optimizing Analytical Release Testing Through Reduced Volume and Turn-around Times

Michael Giffin, ElevateBio

A Matrix Approach to Characterize a Stem Cell-Derived Cell Product During Early Development

Maya Srinivas, BlueRock Therapeutics LP

Is the Vehicle Empty or Full?― Mass Photometry for AAV Capsid E/F Assessment in the GMP Space

Xue (Shelly) Li, Regeneron Pharmaceuticals Inc.

Additional Panelist:

Christopher Storbeck, Health Canada

Michael Giffin

Appearances