Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. This was subsequently followed by the approval of Yescarta® (axicabtagene ciloleucel), a treatment for large B-cell lymphoma that has failed first line treatment. The first two CAR-Ts were joined in 2020 by a third autologous cell therapy Tecartus™ (brexucabtagene autoleucel) for the treatment of relapsed/refractory mantle cell lymphoma. These product launches have spurred further interest in the field and laid the foundation for accelerated development of cell therapy candidates in cancer.
While the first autologous cell therapy commercial products have shown tremendous clinical success, scaling out these therapies while considering individual patient processes is a new challenge.
As autologous cell therapies are patient-specific, a separate batch must be produced for each patient, limiting production standardization across multiple patients. The scale out process is often complex and costly, requiring handling of multiple batches concurrently while maintaining the need for patient-specific customizations. This adds a significant risk profile to the manufacturing process. Close control of collection, shipping, storage, and culture conditions is needed to avoid contamination with other patient batches. Additionally, other considerations such as labelling processes need to be closely monitored to maintain the link between patient and sample(2).