Treg therapies leverage the cells natural immunosuppressive capabilities by harvesting cells from donors, isolating by Treg specific markers, and expanding ex vivo. Tregs can be engineered to target specific antigens similar to CAR-T therapies.
Utilizing Tregs as a therapy can be challenging due to the requirement for specialized equipment and conditions for their isolation and culture, their relative scarcity in circulation, and often a lack of understanding of the Treg TCR diversity and requirements to meet therapeutic endpoints.
Theragent’s GMP facility has been purpose-built to support the development, expansion and banking of novel cellular therapies such as Tregs.
In the appropriate GMP facility, Tregs can be sorted, expanded, and banked for clinical trials. Similar to other immunotherapies, Treg therapies are most often autologous, requiring patient derived material for manufacturing and resulting in issues with starting material integrity, the ability to achieve dose, and all the logistical issues that arise with autologous therapies. In the event a CAR is being loaded onto the Tregs, the additional pain-points of vector procurement and depleted cell health due to transduction/transfection can create a very challenging manufacturing process for these particular therapies.
Theragent has considerable capabilities for process and analytical development of Tregs and other therapeutic modalities. Once the process has been fully developed, 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.