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Assessing Cellular Immunogenicity via ELISpot

As therapeutic modalities have become more complex, such as cell and gene therapies, so too have the bioanalytical methods become more complex for characterizing these therapies. In particular, immunogenicity testing has begun to incorporate more aspects of the patient immune response than what was previously measured. For most protein-based biotherapeutics, immunogenicity measurements focused on anti-drug antibody detection and cytokine production. However, with advanced modalities there is an increase in the use of tools to measure cellular immunogenicity and in particular the use of the enzyme-linked immune absorbent spot (ELISpot). ELISpot measures activated cells by stimulating samples with peptides generated from a protein of interest to determine if the patient’s immune cells are specific for that (potentially) antigenic epitope. This webinar will provide an overview of the ELISpot platform, assay development, regulatory concerns and data analysis/reporting. A live Q&A session with the featured speakers will follow the presentation to answer attendee questions.