Supporting CAR T-Cell Therapy Treatments With Manufacturing Efficiency and Capacity

Chris McDonald

The FDA has approved Kite Pharma’s manufacturing process change for axicabtagene ciloleucel (axi-cel; Yescarta) to reduce median turnaround time from leukapheresis to product release from 16 days to 14 days.1 Time to treatment is an important factor in improving outcomes for patients receiving CAR T-cell therapy.

Axi-cel was approved for the second-line treatment of LBCL in April 2022, for adult patients with disease refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.²

CGTLive® spoke with Chris McDonald, Kite Pharma’s senior vice president and global head of technical operations, to learn more about the manufacturing factors that must be considered in trying to get CAR T-cells to patients. He touched on the manufacturing approval but was not able to share the specific changes made or in which domains the changes were made. He also discussed a newer rapid manufacturing process that Kite is now evaluating in some clinical trial programs.

Why is manufacturing capacity important for patients receiving CAR T?

Chris McDonald: We’re proud of our ability to supply patients. For a patient, if you think about what's important from a turnaround time for them, it's the manufacturing turnaround time and in the success rate, but it's also the capacity to be able to manufacture their product. And I think we're also very proud that we've built out our manufacturing network where, you know, we're a fully integrated cell therapy manufacturing company and we have 5 manufacturing sites globally. We've created the capacity, so the patient doesn't have to wait for a manufacturing slot. And that's also important to be able to get back to the patient as quick as possible.

I think what is unique for cell therapy manufacturing, is you're actually scheduling with the hospital, when the patient's material is going to be manufactured in the plant. And you have to do that coordination. If you're capacity constrained, and you're telling the hospital, I don't have a slot for you for 3 or 4 weeks, then the hospital has to coordinate their time with you. But if you have the extra capacity than the hospital can just schedule it when it makes the most sense for them, knowing that we have the capacity, which is very advantageous for the patient.

Are there other programs or technologies Kite is working to develop or improve?

We're continuously looking at ways to continue to improve, and we do have some things in the works, that are more near term and some things that are more long term. Specifically in our long term goals, we do have in our product portfolio, to implement a rapid manufacturing process. The theory is that you're going to be dosing with more juvenile cells that are more active and require a smaller dose. So, you can manufacture at a faster pace, and we do have products in clinical trials utilizing the newer manufacturing process.

This transcript has been edited for clarity.

REFERENCES

1. Kite Receives U.S. FDA Approval of Manufacturing Process Change Resulting in Reduced Median Turnaround Time for Yescarta® CAR T-cell Therapy. News release. Kite Pharma. January 30, 2024.https://www.gilead.com/news-and-press/press-room/press-releases/2024/1/kite-receives-us-fda-approval-of-manufacturing-process-change-resulting-in-reduced-median-turnaround-time-for-yescarta-car-tcell-therapy
2. FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma. News release. FDA. April 1, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-second-line-treatment-large-b-cell-lymphoma