The Limited Speed of Fast CARs

A closer look at FastCAR/short-culture CAR-T manufacturing approaches and why they are not as fast (in terms of turnaround time) as they appear to be

Executive Summary

• A number of key players, most notably Novartis, Gracell, and BMS are advancing short-culture CAR-T manufacturing platforms that claim to manufacture products within 1-5 days, positioning them as a superior alternative to allogeneic CAR-T approaches that will likely reach market sooner. 

• When you actually account for how long this process will take at commercial scale, including collection, shipping, and release testing, these short-culture approaches don’t appear to reach a lower limit of vein-to-vein turnaround time of about 2-weeks, or a 1-week improvement over Gilead/Kite’s YESCARTA, which has best-in-class manufacturing.

• 2-weeks is a meaningful improvement for turnaround time, however it will be challenging for autologous manufacturing to reach speeds comparable to allogeneic approaches, unless regulatory changes are made that shorten the required 7-day (minimum) release testing period.

• As CARs move into non-oncologic diseases, like the plethora of development that has taken off in the autoimmune space, short-culture approaches may really find their footing, where turnaround times becomes in much larger markets with more stable patients and an autologous product could be preferable to an allogeneic one in immune-competent patients

• It’s a bit unfair to position short-culture CARs as a direct competitor to allogeneic approaches. Both technologies will likely coexist with some patients being better suited for one over the other. Additionally, companies would be wise to showcase the short-culture CARs as the next evolution of autologous manufacturing, offering faster turnaround times, lower COGs, less capacity constraints, and potentially a better therapeutic profile, rather than a direct replacement for allogeneic