10.14.25 -- STREAM Edition: Barriers, Breakthroughs, And Building Access In Pediatric CGTs With Bambi Grilley

During this segment, Nguyen and Wagner agree that scalability will be a top concern for most CGT companies.

This approach enables tissue-level analysis, delivering insights into efficacy at the site of action, uncovering potential safety concerns, and supporting smarter clinical candidate selection.

Explore how rethinking the manufacturing process for cell therapies can accelerate development and commercialization, ultimately benefiting patients waiting for these life-saving treatments.

Whether it's dilution, mixing, cryopreparation, or splitting of cellular products, ReadySelect offers a comprehensive solution for your up- or downstream cell therapy manufacturing workflow.

Discover how to deliver tailored, GMP-compliant automation solutions to your cell therapy manufacturing, which can accelerate innovation from process development to scalable production.

Review the demands for AAV manufacturing using a suspension process and the DOE-based strategy used to achieve a scalable process both in terms production and quality of AAV purified.

Learn how to perform an in situ settle-based media exchange to optimize your cell culture and improve cell growth.

This is Episode 3 of "FDA Fridays," a 4-week special series from Cell & Gene: The Podcast. Host Erin Harris talks to Bambi Grilley, Ph.D., Professor of Pediatrics and the Director of Clinical Research and Early Product Development for the Center of Cell and Gene Therapy (CAGT) at Baylor College of Medicine and Chief Regulatory Officer for ISCT, a leading expert at the forefront of pediatric cell and gene therapy.