In the dynamic landscape of gene and cell therapies (CGTs), the accurate understanding of cell product biodistribution is a pivotal component of monitoring safety and efficacy. This requirement can be met by the emergence of digital polymerase chain reaction (dPCR), a technology enabling precise quantification of DNA. The heightened sensitivity of dPCR over other technologies distinguishes target DNA from genomic background, which is crucial for efficient monitoring of biodistribution in animal models. Our presentation introduces a dPCR workflow tailored for assessing the biodistribution of human CAR-T therapy and leukemia cell lines in rodents. This innovative approach showcases our dPCR workflow's potential to optimize precision and reliability, setting a benchmark for preclinical assessment of investigational cell therapies.
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