CAR-T cell characterization is a critical phase in the development of chimeric antigen receptor T-cell therapies, assuring that engineered T cells possess the desired functional and phenotypic for clinical efficacy and safety. Alfa Cytology employs advanced technologies and assays to provide comprehensive characterization of the functionality and quality of your CAR-T cells.
Characterization of CAR-T cell focuses on assessing the properties and behaviors of engineered T cells throughout their development and clinical use. The scope of the characterization processes encompasses the determination of the CAR-T cells' phenotypes, cytotoxic potential, proliferation rates, and interaction with the tumor microenvironment. Such information on characteristics is critical for predicting the outcome of therapy, optimizing production processes, and regulatory approval.
Fig.1 Image-based cytometry quantifies changes in CAR T cell size post-activation. (Maldini, C. R., et al., 2020)
Our CAR-T cell characterization services strive to provide precise, reliable information on functional and quality-performance aspects of CAR-T products. These comprehensive services use various advanced, state-of-the-art techniques to guarantee that every CAR-T product has undergone adequate evaluation for its preclinical suitability.
CAR-T Cell Expansion Monitoring
Using high-throughput image-based cytometry, CAR-T cell expansion can be precisely quantified. This method allows for the continuous monitoring of cell proliferation and size, ensuring optimal conditions for CAR-T cell growth during manufacturing.
Cytotoxicity Assessment
In vitro cytotoxicity assays are performed to evaluate the ability of CAR-T cells to selectively kill target cells. Both image cytometry and bioluminescence-based methods are utilized to assess the specificity and potency of the CAR-T cells, ensuring they effectively target and destroy tumor cells while sparing healthy tissues.
Phenotypic Profiling
The phenotypic characteristics of CAR-T cells, including memory T cell distribution, activation status, and exhaustion markers, are assessed. This profiling helps determine the functional potential of the CAR-T product and its suitability for clinical application.
Functional Assays
Functional assays measure the release of cytokines, such as IFN-γ, and other markers of immune activation to confirm CAR-T cell efficacy. These tests are crucial for understanding the immune response elicited by CAR-T cells against specific antigens.
T Cell Persistence and Biodistribution
In vivo studies are conducted to assess the persistence of CAR-T cells post-infusion and their ability to home to the tumor site. These studies are vital for understanding the longevity of the therapeutic effect and the potential for sustained tumor clearance.
Tumor Infiltration Assessment
Evaluating the ability of CAR-T cells to infiltrate tumors in animal models is an essential part of characterizing their therapeutic potential. Tumor biopsies and imaging technologies are used to monitor CAR-T cell localization and tumor eradication.
Safety and Toxicity Profiling
In vivo toxicity studies, including monitoring for adverse effects such as cytokine release syndrome (CRS) or neurotoxicity, are integral to ensuring the safety of CAR-T therapies. These evaluations help to predict and mitigate potential risks before clinical trials.
If you're looking to ensure your CAR-T cell products are performing at their best, let's talk. Alfa Cytology is ready to provide detailed characterization that can help optimize your therapeutic cells. Contact us today to discuss your project and discover how our tailored CAR-T cell characterization services can elevate your cell therapy development.
Reference
For research use only.