Spotlight on CAR-T release testing and quality control

The growth of cell therapy around the world means accurate and reliable methods of quantifying dose and circulating cell volume are crucial for ensuring safety and effectiveness. Quantitative PCR (qPCR) involves amplifying the DNA in a sample to a level that is detectable then quantifying the DNA based on a standard curve. It is one of the most common quantitation methods used in laboratories today but the sensitivity to operator error and the reliance on the quality of the standard curve mean that some researchers are looking for alternatives. 

In this spotlight, produced in association with Bio-Rad, we will explore how droplet digital PCR (ddPCR) could be implemented in the CAR-T manufacturing workflow to provide accurate quantitation and improve quality.  We will delve further into potential ddPCR applications, such as quantitating CD19 CAR-T cells from patients treated with axicabtagene ciloleucel (Axi-cel), and survey researchers in the field about their current uses of ddPCR. Finally, we will convene experts in the field to discuss current obstacles and unmet needs associated with advanced therapy release testing and quality control, and share their insights into the future.

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