CAR-T cells are primarily autologous, so the cells are sourced directly from the patient. Several widely available instruments and protocols exist for the selection, expansion, and activation of the desired T-cell subpopulation.
Despite well-documented methods, the manufacturing of CAR-T cells is complex and requires extensive time occupancy of GMP-grade cell equipment. Additionally, the type of CAR engineered into the T cells is often limited by the accessibility of GMP-grade viral vectors, CAR stability, and formulation.
Theragent is the CDMO that can ensure the successful scale-up of your CAR-T therapy.
Cells CQA Defined
Currently, there are six FDA-approved CAR-T therapeutics. These therapies are indicated for immuno-oncology applications in 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, systemic uptake is minimal. The precise targeting of the CAR to the antigen ensures a more potent therapeutic dose.
At Theragent, we overcome the myriad manufacturing challenges associated with CAR-T cells through a multi-channel approach. Our 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 – ideal for CAR-T production. We can provide the tracking of patient samples from vein to vein in a fully transparent and real-time manner, thanks to the support of our fully Pharma 4.0-equipped facility, which also leverages AI to predict and resolve supply chain issues before they occur. We have in-house capabilities that dramatically shorten production times, plus a team of scientific experts in the field of T-cells are a trusted team partner who can work with sponsors to solve problems.
Need the vector for your CAR-T? Leverage our capabilities to produce GMP viral vectors to fully support your CAR-T program.
Taken together, Theragent is the CDMO that can ensure the successful scale-up of your CAR-T therapy.