Genomic Testing – CAR T-Cell Therapy Development

Chimeric Antigen Receptor T-cell Therapy, CAR-T, is a type of cancer immunotherapy that has gained world-wide interest in recent years, especially after FDA approval of CAR-T treatments for B-cell acute lymphoblastic leukemia and large B-cell non-Hodgkin’s lymphoma.  CAR-T therapy utilizes a genetic modification of a patient’s T-cells to express a target that is specific for the tumor antigen. The modified T-cells are expanded in the lab then infused back into the patient to target and kill the tumor cells. Treatment with this therapy has resulted in complete remission in some patients and the modified T-cells are persistent.

To ensure the safety of the CAR-T treatment, regulatory agencies require thorough characterization of the manufactured CAR T-Cells.  In addition, during the clinical trial or patient treatment phase, the level of modified T-cells in patients’ blood must be monitored frequently in a timely manner.

Examples of Genomic Tests for CAR-T Development

  • Next-Gen Sequencing for integration site analysis
  • QPCR Biodistribution Study for preclinical safety study
  • QPCR Copy Number Assay for CAR T-cells lot release
  • QPCR Replication Competent Lentivirus (RCL) Assay for CAR-T cells lot release
  • QPCR or ddPCR for detecting the CAR-T gene in human blood

Avance Biosciences is specialized in assay development, assay validation, and sample testing using DNA sequencing, Next-Gen sequencing, QPCR, ddPCR, and many other biological services in compliance with GLP or cGMP regulations.  We are a leader in providing high quality genomic tests to support our clients in their CAR-T therapy development efforts.



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