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.

Person Leukapheresis

Transfer To Cdmo

Isolate Cells

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.

Transduce

Expand Cells

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.

Harvest Cryopreserve V3

Quality Control

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.

Transfer To Patient

➐ Infusion

Engineered Treg product is administered intravenously, delivering the cells directly into the patient’s bloodstream. .

Infusion

Our team consists of industry leaders with numerous published works.