Assess CGT with ELISpot and FluoroSpot | Mabtech

ELISpot and FluoroSpot assays play a crucial role in the development of cell and gene therapies (CGT). They provide important insights into the functionality of CAR-T cells, TIL activity, the efficacy of cancer vaccines, and gene therapies that use viral vectors. The FDA recommends cytokine secretion assays for assessing these therapies, ensuring a clear path to success.

New cell and gene therapies (CGT) are rapidly advancing, treating various diseases by modifying or introducing genes to restore function. The FDA emphasizes comprehensive immune analysis, highlighting cytokine secretion assays as essential for evaluating efficacy and safety. While flow cytometry offers valuable insights, it may not capture the detailed cytokine profiles needed. ELISpot and FluoroSpot fill this gap, providing detailed maps of cytokine secretion responses at the cellular level.

CAR-T cell therapies reprogram a patient’s T cells to target cancer, resulting in six FDA-approved treatments for blood cancers. Cytokine release assays are crucial for developing CAR-T cells, ensuring safety and efficacy. In vitro potency assays like cytotoxicity and flow cytometry test CAR-T cell activation and functionality, with ELISpot and FluoroSpot providing sensitive detection of cytokine-secreting cells.

TIL therapies, like the FDA-approved Lifileucel for melanoma, use a patient’s tumor-infiltrating lymphocytes to boost immune response. ELISpot and FluoroSpot are essential for measuring TIL functionality, activity, and potency during manufacturing and assessing responses to autologous tumors, changes in TIL composition, and pyrogen testing.

Cancer vaccines stimulate immune responses against tumors using various approaches, such as nucleic acid-based, cell-based, viral-based, and peptide-based vaccines. ELISpot and FluoroSpot assays are invaluable for evaluating vaccine efficacy, measuring specific immune responses through cytokine secretion.

Gene therapies aim to correct genetic disorders by delivering functional genes using viral vectors like AAV. Immune response assessment is crucial, with ELISpot and FluoroSpot assays providing detailed insights into T cell-mediated immunity and innate immune responses, complementing traditional antibody detection methods.

Overall, ELISpot and FluoroSpot assays are indispensable for CGT development and evaluation, offering detailed immune response data critical for advancing clinical trials and emerging therapies.