Cell Types We Support

T-Cells: CAR-T

Chimeric antigen receptor T-cells (CAR-T cells) are genetically modified T-cells with highly specific disease-targeting capability. The CAR binding domain is displayed on the surface of the T-cells to attach to the desired antigen. Upon binding to the antigen, the CAR-T cells are activated and become cytolytic, and the immune cascade follows to eliminate the diseased cells.

The Approach

Currently commercialized CAR-T cells are all autologous, so the cells are sourced directly from the patient. Allogeneic CAR-T cells are in development and can help increase availability while driving down the cost of manufacturing. Several widely available instruments and protocols exist for the selection, expansion, and activation of the desired T-cell subpopulation. Theragent can work with existing CAR-T processes or develop new protocols depending on client needs.  

The Challenge

Despite well-documented methods, the manufacturing and distribution of CAR-T cells has a number of significant challenges, including the lack of a common platform for production, the need for sourcing GMP grade vectors (i.e., lentivirus, transposon), the facility requirements for scaling out manufacturing, and cold-chain logistics & uniqueness of processes at the clinical site.

Theragent is the CDMO that can ensure the successful scale-up of your CAR-T therapy.

  • Patient Collection

  • Cells CQA Defined

  • Bioprocessing

  • Testing Standards

Currently, there are six FDA-approved CAR-T therapeutics. These therapies are indicated for immuno-oncology applications in leukemia, lymphoma and multiple myeloma treatments. CAR-T cells offer several advantages over traditional cancer therapies. Because CAR-T cells are highly specific for their designated antigens, are a living therapy that can adapt to the environment, and can live long term in the host continuing to surveil for relapse, there has been a highly significant increase in long-term survival in patients refractive to other treatments. The precise targeting of the CAR to the target antigen ensures a more potent therapeutic dose while limiting general toxicities such as those seen in radiation and chemotherapy treatment.

At Theragent, we overcome the myriad of manufacturing challenges associated with CAR-T cells through a multi-channel approach. Our state-of-the-art cleanrooms are outfitted with the latest instruments and technologies to provide the most efficient manufacturing. Our kitting room is strictly designated to manage, disinfect, and package all single-use components prior to entering manufacturing suites; reducing risk to your production. Our electronic systems provide full vein-to-vein chain-of-custody traceability for patient samples, real-time off-site monitoring of the production process, seamless materials management, production scheduling and quality oversight, and leverages AI to predict and resolve supply chain issues before they occur. We have in-house capabilities and processes that dramatically shorten the time from starting material to product disposition and we conduct a broad suite of in-house analytics to ensure timely and accurate results. Our team of scientific experts in the field of T-cells are a trusted team partner who can work with sponsors to streamline processes, optimize analytics, and solve problems along the entire workflow.

Taken together, Theragent is the CDMO that can ensure the successful scale-up of your CAR-T therapy.