Chimeric antigen receptor (CAR) T cell therapy has proven to be very effective in treating hematologic malignancies, and major efforts are being made to achieve similar efficacy in solid tumors. Along with the development of CAR-T therapy, the biodistribution of CAR-T cells which is the basis of their effectiveness and safety, has aroused much attention. For IND application, the biodistribution characteristics of CAR-T cells are required to be determined using at least two methods (both quantitative and qualitative evaluation could be applicable) for a comprehensively understanding of their potential target organs/tissues. As a service provider in the field of cell therapy for over 10 years, Creative Bioarray is capable of offering CAR-T biodistribution analysis service in the most high-quality and cost-effective way. And we focus on the RNA ISH assay that can provide CAR-T biodistribution data for every tissue type.
Adoptive cell therapy is currently being used in at least 270 active clinical trials in the world. However, variability in clinical outcomes and the incidence of harmful side effects has challenged researchers to implement methods to validate CAR-T cell biodistribution and pharmacokinetics in the body. In fact, the United States Food and Drug Administration (FDA) published guidelines specifying that investigational cell therapy should incorporate some means of cell tracking to determine in vivo cell survival, anatomic engraftment and biologic activity throughout the product development cycle, preferably starting at the preclinical stage. However, current methods are either not sensitive enough to detect low levels of expression or not capable of detecting CAR+T cells in the tissue context.
The high specificity and single-molecule sensitivity of the RNA in situ hybridization and ImmunoFISH (FISH+IHC) technology for the detection of gene expression in the tissue context make them a key tool for the stringent assessment of "on-target/off-tumor" gene expression. The key advantage of the RNA in situ hybridization and ImmunoFISH (FISH+IHC) assay for CAR detection is its ability to target the viral untranslated regions (UTRs) of the CAR transcript, which can be used as unique sequence tags of CAR+ T cell detection in both animal and human tissues. The RNA in situ hybridization and ImmunoFISH (FISH+IHC) assay can also be multiplexed for simultaneous detection of CAR, cytokines, T cell markers and other markers. Taken together, the CAR-T Biodistribution from Creative Bioarray provides an unparalleled sensitive and specific method for cell- and tissue-specific assessment of preclinical CAR-T targets as well as tumor infiltration of activated CAR-T cells.
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