5-day release strategies for autologous CAR-T Phase I products
On demand

5-day release strategies for autologous CAR-T Phase I products

Wednesday 09:00 PDT / 12:00 EDT / 16:00 GMT / 17:00 CET
5-day release strategies for autologous CAR-T Phase I products

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

Children’s GMP, LLC (CGL) manufactures biotherapeutics to support Phase I/II clinical trials sponsored by investigators at St. Jude Children’s Research Hospital. CGL has been manufacturing cellular therapy drug products since they opened in 2003. CGL manufactured their first CD19-CAR-T drug product for a St. Jude patient in 2018 and since then, have opened multiple CAR-T Phase I/II clinical trials.

The focus of the talk will be on how the CGL Quality Control (QC) department has adapted over the years to develop rapid CAR-T platform release testing assays to improve the efficiency, capacity, and speed in which the drug products are characterized, released, and made ready for patient administration. The QC department at CGL has developed a 5-day Release Testing Strategy by continuing process improvements and incorporating new testing technologies and techniques.

Key highlights of the discussion include:

  • St. Jude's influence on turnaround times - Uncover how the unique environment at St. Jude Children's Research Hospital has spurred the development of swift turnaround times for releasing pediatric CAR-T therapies.
  • Platform-based assays: a release testing strategy - Delve into the intricacies of our release testing strategy, leveraging platform-based assays to ensure precision and reliability in characterizing CAR-T therapies.
  • Current landscape: improving rapid tests - Gain insights into our ongoing efforts to enhance rapid tests, aiming to elevate release testing efficiency and capacity. Learn how we are committed to maintaining critical CAR-T drug product releases within an impressive 5-day timeframe post-manufacturing.
Catherine Willis
Catherine Willis
Director, Quality Control at Children's GMP, LLC

Dr Catherine Willis earned her PhD from Northwestern University, Feinberg School of Medicine in 2013. Following the completion of her graduate degree, she delved into postdoctoral research at St. Jude Children’s Research Hospital within the Developmental Neurobiology Department. 

In 2015, Catherine transitioned into the role of Senior Scientist I within the Quality Control Department at Children’s GMP, LLC, an asset of St. Jude Children’s Research Hospital. Since then, her journey within the organization has been marked by continuous growth. Catherine has progressed through various leadership roles within the organization, starting as the Quality Control Flow Cytometry Manager in 2018 and Manager of the QC Department in 2019. She has consistently played a pivotal role in shaping the trajectory of the quality control processes for Children’s GMP, LLC.

In her current capacity as the Director of Quality Control, Catherine is instrumental in overseeing and directing the design of efficient and compliant quality control testing for products manufactured by Children’s GMP, LLC. The biologics manufactured by Children’s GMP, LLC support Phase I/II clinical trials at St. Jude Children’s Research Hospital or other collaborating institutions to further the research and understanding of treating childhood disease.

Pavle Matak
Pavle Matak
Business Development Manager, dPCR at QIAGEN
Dr Pavle Matak is the Business Development Manager for dPCR at QIAGEN. He is an accomplished bench and field scientist with a background in neurodegeneration, immunity, and genetics. Pavle obtained his PhD is in Molecular Genetics from King's College London.