Treg therapies leverage the cells’ natural immunosuppressive capabilities by harvesting cells from donors, selecting for specific markers, and expanding ex vivo. Tregs can be engineered to target specific antigens, similar to CAR-T therapies.
Expanding Tregs ex vivo can be challenging due to safety validations and cell banking requirements by regulatory authorities.
Theragent’s GMP facility has been purpose-built to support the development, expansion and banking of novel cellular therapies such as Tregs.
Treg therapies are currently in clinical trials for autoimmune disorders of the central nervous system, graft versus host disease, irritable bowel syndrome,
and amyotrophic lateral sclerosis.
In the appropriate GMP facility, Tregs can be sorted, expanded, and banked for clinical trials. Treg therapies may involve autologous transplants, which requires single-use consumables for manufacturing. In the event a CAR is being loaded onto the Tregs, formulation development must optimize the CAR for the Tregs environment in vivo.
Theragent’s GMP facility has been purpose-built to support the development, expansion and banking of novel cellular therapies such as Tregs. Connect with our T cell experts to learn more about our unique capabilities.