The FDA Bioanalytical Method Validation (BMV) guidance is not always applicable and may need to be adapted to the unique properties of ELISpot to achieve a fit-for-purpose validation.
TORONTO, Ontario (PRWEB) November 30, 2021
The enzyme-linked immunosorbent spot (ELISpot) assay is widely recognized as a powerful tool to monitor immune system responses to therapeutic agents. Specifically, B-cell ELISpot provides information on antigen-specific antibody-secreting cells while antigen-specific T-cell response data yields valuable insight during clinical studies.
Join this webinar to learn how immune monitoring assays, such as ELISpot and intracellular cytokine staining (ICS), provide unique challenges in a regulated environment as no reference material or gold standard is utilized. The FDA Bioanalytical Method Validation (BMV) guidance is not always applicable and may need to be adapted to the unique properties of ELISpot to achieve a fit-for-purpose validation.
The frequent use of ELISpot in clinical trials highlights its importance to a wide variety of fields, such as HIV and other infectious diseases, oncology, autoimmunity, gene therapy and vaccines. Over 400 clinical trials used ELISpot as a primary or secondary endpoint. Global harmonization efforts for ELISpot application include the creation of optimized assay protocols, counting guidelines, targets for precision as well as linearity and response definitions.
Register for this webinar in which expert speakers will address the challenges of measuring a complex immune biomarker in the bioanalytical environment by utilizing a comprehensive validation and bioanalytical study plan, including clear guidance for sample collection.
For more information, or to register for this event, visit Clinical and Bioanalytical Aspects of Immune Monitoring via ELISpot.
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