Manufacturing
Autologous cell therapy is redefining medicine, with manufacturability as a critical success factor.
Leveraging our experience in regulatory T cell (Treg) manufacturing we have established a robust process to deliver reliable, scalable production.
➊ Leukapheresis
White blood cells, or leukocytes are collected from the patient’s blood.
➋ Isolate Cells
Tregs are isolated from the white blood cells using a combination of surface markers and cell-sorting techniques then stimulated with anti-CD3/anti-CD28 beads plus IL-2.➌ Transduce with CAR
A viral vector is used to deliver a chimeric antigen receptor (CAR) into the Treg.
➍ Expand Cells
Tregs are supplemented with interleukin-2 (IL-2), a growth factor that promotes their expansion.➎ Harvest & Cryopreserve
Following expansion, Tregs are collected and cryopreserved through a carefully controlled process to preserve their function and viability for therapeutic use.
➏ Quality Control
Manufacturing engineered Tregs involves a complex, multi-step process, followed by rigorous quality control to ensure product identity, purity, potency, viability, sterility, and stability.
➐ Infusion
Engineered Treg product is administered intravenously, delivering the cells directly into the patient’s bloodstream.