The enzyme-linked immunosorbent spot (ELISpot) 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 interferon-gamma (IFN-γ), yield 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. With recent advances in mRNA vaccines, understanding the durability of the cellular immune response compared to other modalities will expand the 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.
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 peripheral blood mononuclear cells (PBMCs), 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.
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.
Wendy Adamowicz, MS, Senior Scientist, Celerion
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.
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).
Who Should Attend?
This webinar will benefit those working in the research areas of infectious diseases, oncology, autoimmunity, gene therapy and vaccines, with relevant job areas/titles including:
- Pharmaceutical Professionals
- Clinical Scientists
- Bioanalytical Scientists
- VP Clinical Operations
- Director of Clinical Operations
What You Will Learn
Join this webinar to learn:
- Clinical applications of ELISpot
- Critical components of ELISpot validation, including sample handling and collection
- Bioanalytical study design for sample analysis
Celerion, a global leader in early clinical research services offers a unique combination of medical expertise, clinical operations experience and scientific excellence that gives our clients the confidence to make fast, accurate decisions about their drug development path. For fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic and pharmacodynamics studies in highly controlled clinic environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism and excretion studies as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. Celerion offers feasibility, data management, biostatistics, clinical monitoring and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends and people in need around the world. For more information, please visit www.celerion.com.