T-Stim™ Production Process

T-Stim™ is manufactured from the blood of normal donors and is expanded and differentiated ex-vivo.  One blood donor can produce enough T-Stim™ to treat 50-100 patients.  The manufactured T-Stim™ is aliquoted into individual dosages and stored in liquid nitrogen.  The frozen product can be distributed through hospital pharmacies.

The T-Stim™ production process involves: (1) purifying precursor immune cells from the blood (from leukapheresis source material) of normal screened donors; (2) culturing the precursors in the presence of custom monoclonal antibodies (mAbs) conjugated to a biodegradable tissue-like matrix (patent pending) simulating a lymph node (the mAbs provide maturation signals to the precursor cells and cause them to expand and acquire the beneficial immunomodulatory and stimulatory characteristics of T-Stim™ cells); (3) aliquoting the resulting cultured T-Stim™ cells into single dosage forms; and (4) freezing the aliquoted T-Stim™ cells in liquid nitrogen for long-term inventory storage. 

At the point-of-care, the T-Stim™ cells are thawed and washed.  Prior to infusion, the T-Stim™ are activated by adding  TAP™ reagents (particles coated with monoclonal antibodies).  The combination of T-Stim™ and TAP™ is called AlloStim™.