The evolving landscape of cell and gene therapy (CGT) development presents unique comparability challenges that extend beyond those encountered with traditional biopharmaceutical products. This session will explore scenarios where conventional comparability approaches must be adapted because of accelerated clinical timelines, the complexity of CGT products and processes, and / or the scarcity of materials.

Speakers will share strategies for comparability assessments for process changes, facility transfers, and method transitions when analytical sample retention is limited or impossible. The session will also provide insight into innovative risk-based statistical and scientific approaches to overcome small sample sizes, including considerations for leveraging prior knowledge, platform experience, and historical data to inform and strengthen comparability assessments.

By attending this session, attendees will have the opportunity to hear dialogue between industry and regulators on pragmatic, science-driven comparability strategies that maintain product quality and patient safety while enabling the efficient advancement of these transformative therapies to patients.

Session Speakers:

Manufacturing Changes and Comparability for Cell and Gene Therapy Products

Andrew Timmons, CBER, FDA

Risk‑Based Analytical Comparability for am AAV Gene Therapy After an Early Manufacturing Site Change

Sam Sathiamoorthy, AspireBio Consulting

Progressive Analytical Comparability Strategy for an Autologous CAR-T Cell Therapy Product Across Multiple Process Changes and Manufacturing Sites

Houman Dehghani, Cabaletta Bio, Inc.

Additional Panelist:

Christopher Storbeck, Health Canada

Seshu Tyagarajan

Appearances