Immunomodulator Potential Evaluation by Immune Cell Function Assays
Our immune functional assay portfolio can be applied to assess a compound’s potential to act as an immunosuppressor or an immunostimulator. We can provide you with fully integrated services to support toxicology and clinical studies that address safety and pharmacology requirements. Our experience will help guide you to the most appropriate set of assessments.
Functional Assays for Measuring Humoral & Cellular Immune Responses
Many immune function assays are applied across the development path. Immunological assays tailored for your therapeutic may be applied and refined from initial candidate selection, through non-clinical, and into clinical. We offer a wide range of platforms for immune function studies. As these functional assays involve a broad range of formats and readouts, the selection of an appropriate platform is critical. Through our collaboration, we can help you select an appropriate platform to ensure a balance between sensitivity, speed, and cost.
eGuide: Biomarker Solutions from Discovery to Clinical Trials
Learn how strategic biomarker integration can accelerate research & de-risk pipelines to bring life-saving therapies to patients faster. This guide helps you uncover smarter ways to de-risk studies and accelerate timelines, without compromising scientific rigor.
Read the Guide
Available Immune Functional Assay Platforms:
- ELISpot and FluoroSpot
- Neutrophil/Macrophage (flow cytometry)
- Oxidative burst activity
- Phagocytosis
- Migration
- Complement (ELISA, flow cytometry)
- Cytokine/Chemokine (ELISA Multi-plexing, flow cytometry)
- Profiling
- Release
- Cell proliferation (beta counter, flow cytometry)
- T-cell-dependent antibody response – TDAR (ELISA) in vivo functional assay to characterize immune response to an immunogen
- Immunophenotyping (flow cytometry), an important endpoint to evaluate the impact of a pharmaceutical compound on the immune system
- Natural killer (NK) cell activity (gamma counter, flow cytometry)
- Mast cell & Basophil (flow cytometry)
- T-cell cytotoxicity
- ADCC/CDC (flow cytometry)
- Extended histopathological examination: lymphoid tissues and organs
- CD8+ T-cell response model (adenovirus-based vaccine)
- Delayed-type Hypersensitivity (DTH) evaluation: multiple readouts (clinical and microscopic examination at the challenge site)
- IFN-gamma and IL-4 ELISpot
- Immunohistochemistry at challenge site
Our team of scientists can streamline your transition from discovery to safety assessment ensuring progression of functional assays, and that those immunological assays remain appropriate throughout evolving context.
Expand Your Expertise: Leverage Current Tools to Accurately Evaluate T-cell Response Webinar
Review previous case studies, uncover lessons learned, and identify how to select the optimal assay for your customized program.
Application by Therapeutic Area or Modalities
Immune cell function assays are used broadly across therapeutic classes.
- ELISpot assessments may not only be applied in the context of vaccine programs, but also in some gene therapy applications.
- Our experience with TDAR assays and the development of immunophenotyping panels specific to the pharmacological action of a drug means that we ensure the bioanalytic endpoints employed are specifically tailored to the needs of your program.
- Our experience with CD8+ T-cell response assay allows us to monitor CD8 directed therapeutic drugs with different endpoints (ELISpot, CTL, flow cytometry).
The breadth of approaches to study the activity of immune function can be daunting. While in many cases the general areas of focus can be defined by the pharmacological action of a candidate therapeutic, there may still be several possible analytical approaches for consideration. We can help guide you to select the appropriate endpoints and immune functional assays at each stage of the drug development journey.
Frequently Asked Questions (FAQs) About Immune Function Assays
-
Do you run these immunological assays as standalone studies, or can they be integrated in the toxicology studies?
These assays can often be integrated in your GLP toxicology studies as exploratory or pharmacodynamic fit-for-purpose assays, although many of the endpoints are also available as validated/GLP assays in different species.
-
Can samples be processed at the test site or are samples shipped for analysis?
In most cases fresh sample processing is optimal for immune function testing. Therefore, various test sites have immunology laboratory capabilities on site for same day processing as the collection of flow cytometry, ELISPOT, and other functional assays.
-
Which immunological assays are available for which species?
Various immune cell function assays are available for most of the standard preclinical species as well as clinical samples.
-
Can you perform immunological assay on clinical samples?
Clinical sample (e.g., fresh whole blood vs. frozen PBMC) analysis can be performed when the appropriate sample handling, storage, and/or shipment conditions can be applied for the relevant endpoint (i.e., flow cytometry, ELISPOT).