ELISpot method development and validation for gene therapies: building on 2019 WRIB recommendations, practical case studies, lessons learnt and evolving trends


Unlike ADA- or NAb-detecting protocols, there is no regulatory guidance currently for how to develop and validate ELISpot methods. The recommendations in the 2019 WRIB White Paper outlining ELISpot assay expectations and performance criteria are therefore meant to harmonize practices and standardize approaches, especially in light of the fact that ELISpot assays require a complex workflow from sample collection to testing. In this webinar, PD Dr. Arno Kromminga and Dr. Juliane Ober-Blöbaum will take a closer look at how to minimize the variability of ELISpot results by controlling the sample collection and handling process as well as by standardizing the peripheral blood mononuclear cells (PBMC) preparations. They will also step through a real-world case study discussing the process of validating an ELISpot assay for the qualitative assessment of cellular immune responses against a virus-based gene therapy.

What will you learn?

In this webinar, you will discover:

  • What the 2019 WRIB White Paper outlines as its recommendations for ELISpot assay expectations and performance criteria
  • The complexities in the ELISpot assay workflow that can contribute to variability of results
  • Techniques and processes to minimize variability of ELISpot assay results
  • An example of how an ELISpot assay for the qualitative assessment of cellular immune responses against a virus-based gene therapy was successfully validated

Who may this interest?

  • Pharma
  • Biotech
  • Academia
  • Medicine


Dr. Arno KrommingaPD Dr. Arno Kromminga
Chief Scientific Advisor
BioAgilytix (Hamburg, Germany)

PD Dr. Arno Kromminga is a certified specialized immunologist with 20+ years of expertise covering the entire cascade of assay strategy and characterization of immune responses against biological therapeutics. Dr. Kromminga is an esteemed senior expert in autoimmunity, allergy and other immune mediated diseases, including assay development and clinical interpretation of laboratory parameters. Dr. Kromminga is invited to speak at numerous international scientific conferences and has authored multiple peer-reviewed scientific publications in journals and text books.

Juliane Ober-BlöbaumDr. Juliane Ober-Blöbaum
Principal Investigator
BioAgilytix (Hamburg, Germany)

Dr. Juliane Ober-Blöbaum is a Principal Investigator at BioAgilytix’s European headquarters in Hamburg, Germany. She has specialized expertise in dendritic cell development and their assessment and characterization. Dr. Ober-Blöbaum received her Ph.D. in Biology from RWTH Aachen University and completed a senior post-doc at the University Medical Center, Johannes Gutenberg University in Mainz, Germany.

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