Clinical and Bioanalytical Aspects of Immune Monitoring via ELISpot, Upcoming Webinar Hosted by Xtalks

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In this free webinar, the featured speakers will discuss the clinical applications of immune monitoring assays such as the enzyme-linked immunosorbent spot (ELISpot) assay. Attendees will hear about the critical components of ELISpot validation, including sample handling and collection, and bioanalytical study design for sample analysis.

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 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.

Join experts from Celerion, Wendy Adamowicz, MS, Senior Scientist; and Aernout van Haarst, PhD, Director, for the live webinar on Thursday, December 16, 2021 at 11am EST (4pm GMT/UK).

For more information, or to register for this event, visit Clinical and Bioanalytical Aspects of Immune Monitoring via ELISpot.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Ayesha Rashid
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