Scaling autologous CAR-T manufacturing for autoimmune and larger patient populations

Thursday 09:00 PDT / 12:00 EDT / 16:00 GMT / 17:00 CET

Sponsor

Scaling autologous CAR-T manufacturing for autoimmune and larger patient populations

Autologous CAR-T manufacturing was originally built around large hematological oncology patient volumes. Similarly, serving autoimmune and other larger indications requires producing for populations in the thousands to tens of thousands, and achieving cost -of -goods levels that current workflows were not designed to meet.

This panel discussion examines whether autologous CAR-T production can be automated, decentralized, and scaled to meet this demand. Building on our Special Interest Group on the future of CAR-T cell therapy, panellists from ElevateBio, Bristol Myers Squibb, Autolus Therapeutics, and Cabaletta Bio will discuss the practical bottlenecks that determine whether target volumes for autoimmune indications are achievable, including throughput per suite , release testing and vein-to-vein time.

Attend this panel discussion to:

Identify which steps in the autologous workflow can be closed and automated with today's systems, and where per-suite throughput currently plateaus
Understand how to characterize CAR-T safety, including the risk of insertional oncogenesis, sufficiently to justify treatment in otherwise healthy populations such as patients with severe allergies
Learn how process comparability can be maintained and demonstrated to regulators when manufacturing shifts to decentralized or point-of-care sites
Assess where release testing, cryopreservation, cold chain, and vein-to-vein time constrain throughput, and whether rapid or fresh (non-cryopreserved) manufacturing can ease the bottleneck

Register now to hear how the field is planning to make autologous manufacturing viable at the scale required for autoimmune indications.

Stephan O. Krause, PhD

Executive Director for Analytical Strategy at Bristol Myers Squibb

Stephan O. Krause, PhD, is a biopharmaceutical quality and analytical science leader with over two decades of experience advancing global standards across biologics, cell therapies, and analytical control strategies. As Executive Director for Analytical Strategy at Bristol Myers Squibb, he leads analytical strategy development and lifecycle execution for cell therapy products across global sites. Stephan brings a rare blend of deep technical skills and strategic standard-setting experience, having held leadership roles at AstraZeneca, MedImmune, Bayer, and other companies. He is the recipient of over a dozen publication and industry recognition awards and is known for his PDA leadership. He currently serves on several advisory boards and chairs several high-impact task forces, including PDA TR for Phase-Appropriate QMS for ATMPs and ANS-07 Analytical Standard Development. He earned his PhD in Analytical Chemistry and Biochemistry from the University of Southern California, where his research explored enzymatic mechanisms through isotope-labeled ATP hydrolysis studies.

Katie Jorgensen, MS

VP, Site Head, BaseCamp Waltham at Elevatebio

Katie Jorgensen joined ElevateBio in 2021 and as Site Head at BaseCamp, she is responsible for supply chain, facilities, technical operations, manufacturing, and program management supporting strategic contracts and valued partnerships bringing innovative cell and gene therapies to patients. Previously, she was the Company’s VP, Commercial Operations and CMC Program Management.

Kurtis Carlisle

VP at Cabaletta Bio

Kurtis Carlisle is a biotech supply chain leader with nearly two decades of experience guiding teams and building global networks to bring therapies to patients. He currently serves as Vice President of Supply Chain at Cabaletta Bio, where he oversees end-to-end supply chain strategy, vendor partnerships, and patient operations to support autologous cell therapy programs in clinical development. Since 2021, Kurtis has been deeply engaged in the cell therapy industry, leading supply chain and external manufacturing functions that enable patient-specific therapies to advance through clinical trials and toward commercialization. Throughout his career, Kurtis has held senior leadership roles at companies including TCR² Therapeutics, Viela Bio and AstraZeneca, where he built and led supply chain organizations that supported everything from first-in-human trials to global commercial launches. His expertise spans demand and supply planning, global distribution, cGMP operations, and organizational development, with a consistent focus on creating scalable systems and teams that enable innovation.

Alaina Schlinker, PhD

Director, Global Field Application Support at Fresenius Kabi

Alaina Schlinker leads Global Field Application Support for Fresenius Kabi’s Lovo and Cue cell processing systems. Her team partners with therapy developers to integrate automated platforms from pre-clinical process development through commercial manufacturing. With more than a decade in cell and gene therapy, Alaina has played a key role in the evolution of the Lovo system and contributed to the launch of Cue. She holds a PhD in Chemical Engineering from Northwestern University.