Chimeric Antigen Receptor T-cell (CAR-T) therapy is a cell and gene therapy modality where a patient’s immune T cells are genetically modified in the laboratory to bind to cancer cells. This is done by engineering a cell-membrane antibody fragment in such a way that it recognizes a specific protein expressed only in cancer cells. Once injected into the patient, the CAR-T cells stimulate the immune system through internal signaling domains connected to the antibody fragment, allowing T cells to identify and kill the cancer cells specifically. The T cells are typically derived from the patient (autologous) or other donors (allogeneic).

Research into this unique modality has been gathering momentum in recent times. Since 2017, six CAR-T therapies for blood cancers have been approved. Despite the high costs ($0.5M/patient), manufacturing bottlenecks, and safety concerns, the cell and gene therapy market is projected to grow at a CAGR of 29.8% from $8.44B in 2023 to 88.2B in 2032 (Precedence Research, 2023).

In this viewpoint article, we explore the top challenges in developing CAR-T therapy for treating cancer and how leading CRO-CDMO Syngene supports clients in bringing this therapy to patients faster.