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European Biopharmaceutical Review

Droplet Digital PCR for Safe and Effective CAR T Cell Therapies

Since the FDA approved the world’s first chimeric antigen receptor (CAR) T cell therapy in 2017, more than 100 treatment centres across the US have become certified to administer this treatment to patients. According to one forecast, the global market for CAR T cell therapies is expected to grow 34.5% every year to a total of nearly $8 billion by 2026. CAR T cells are gaining popularity because they represent a new generation of personalised cancer therapies that use genetic modification to attack tumours. While the therapeutic promise of CAR T cells is high, the process of generating these cells is complex and, therefore, requires close monitoring of safety and effectiveness using quality control technologies such as droplet digital polymerase chain reaction (ddPCR).

CAR T cells are made from each patient’s own T cells. After being extracted from a patient’s blood, the cells are activated and genetically modified using viral vectors, transposon systems, or mRNA transduction to express the CAR protein. Finally, the cells are expanded in vitro, and with their new ability to target specific proteins on tumour cells, they are injected back into the patient. CAR T cell therapies are currently approved to treat relapsed or refractory liquid tumours in acute lymphoblastic leukaemia, diffuse large B-cell lymphoma, and mantle cell lymphoma. In clinical trials for the most recently approved CAR T cell therapy, 87% of patients with refractory or recurring mantle cell lymphoma responded to a single treatment, while 62% of the patients had a complete response.

The Challenge of Generating Safe and Effective CAR T Cells

Unlike synthetic drugs, CAR T cells are a living therapy, and transforming them into safe and effective cancer treatments is not simple. For example, one barrier to the generation of safe and effective CAR T cells is the integration step – when the CAR transgene is introduced to the T cell. It is impossible to completely control how many copies of the gene will integrate and where the copy will integrate into the cells’ genomes.

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Mark White is the Associate Director of Biopharma Product Marketing atBio-Rad. He has played a key role in the development of multiple core technology capabilities and assays alongside a multidisciplinary team of biologists and engineers at Bio-Rad and previously at Berkeley Lights Inc. Mark obtained his PhD in Biomedical Sciences at the University of California, US.
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