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Clinical and Bioanalytical Aspects of Immune Monitoring via ELISpot

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The Elispot (Enzyme-linked immunosorbent spot) assay is widely recognized as a powerful tool  to monitor the immune system in response to therapeutic agents. Specifically, B-cell Elispot  provides information on antigen specific antibody secreting cells, including memory B cells. In  addition, antigen specific T-cell responses, most commonly measured by IFN-γ, yield valuable  insight during clinical studies. 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 (GT) and vaccines. With recent advances in mRNA vaccines,  understanding the durability of the cellular immune response compared to other modalities will  expand understanding of mechanisms for new vaccine technologies. Over 400 clinical trials used  Elispot as a primary or secondary endpoint. Consequently, the quality of the data stemming from  point of collection to statistical analysis is paramount. 

Immune monitoring assays such 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. Global  harmonization efforts for Elispot application include the creation of optimized assay protocols,  counting guidelines, targets for precision and linearity, and finally response definitions. Sample  collection and processing methods for PBMCs (peripheral blood mononuclear cells), including  mechanisms of suppression of T-cell functionality, are thoroughly explored within the literature.  Although key to preserving the responsiveness of the PBMCs, sample collection and handling is  still an area often neglected at the validation stage. 

We 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, validation components, and appropriate statistical testing  carried out within the framework of a GLP environment.


Wendy Adamowicz, MS, Senior Scientist, Celerion Inc.

Wendy Adamowicz, MS is a Senior Scientist in the Molecular and Cell Biology group within Bioanalytical Services at Celerion. Her focus is on method development and validation of ELISpot, qPCR, flow cytometry and biomarker assays. Wendy joined Celerion in 2016, bringing over 20 years of pharmaceutical experience in assay development and target validation for both large and small molecule programs in oncology, psychotherapeutics and neurodegeneration.

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Aernout van Haarst, PhD, Director, Scientific Affairs, Celerion

As Director, European Corporate Development, Dr. Aernout van Haarst plays a key role in supporting the growth of new services at Celerion. By leveraging his scientific and drug development expertise, Dr. Van Haarst is focused on identifying and building partnerships with specialist early-phase organizations in Europe to meet their clients’ evolving needs.

Dr. van Haarst has over 25 years of drug development experience at CROs as well as biotechnology companies. This experience includes designing drug development strategies as well as hands-on experience in the design and conduct of early clinical studies in a breadth of therapeutic areas, including all clinical operational management and regulatory authority meetings. He led the set-up of a Phase I clinical research unit from inception in Spain, and assumed all management responsibilities, including operational, regulatory compliance, financial and business development. Dr. van Haarst has a unique blend of entrepreneurial business skills balanced with a strong scientific and operational background.

Dr. van Haarst earned his Doctorate in Pharmacology from the School of Medicine at Leiden University (Netherlands) and qualified as a Clinical Pharmacologist in Leiden. He has a doctoral degree in Medical Biology from the School of Medicine at the University of Utrecht (Netherlands).

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Key Takeaways

  • Clinical applications of Elispot 
  • Critical components of Elispot validation including sample handling and collection
  • Bioanalytical study design for sample analysis 

Audience Consists of Pharmaceutical Professionals, Clinical Scientists, and Bioanalytical  Scientists in the Following Fields and Professions (Who Should Attend): Infectious Diseases,  Oncology, Autoimmunity, Gene Therapy (GT) and Vaccines. 

  • VP Clinical Operations
  • Director of Clinical Operations