Immunological Assays

A global network of scientific, technical, and support personnel is ready to work with you to efficiently deliver your therapeutic program. Our team can provide you with scientific expertise on immune system function, an up-to-date knowledge of regulatory expectations, and established immunology testing. Navigate the challenges of selecting the most appropriate immune-related endpoints by leveraging our knowledge and experience.

Our experience covers standard endpoints of immunology testing, such as immunophenotyping, receptor occupancy, cytokine analysis, and immunogenicity assessment.

If you have a program with challenging immunotoxicity considerations, we’ll work with you to develop the required analytical methods to conduct safety testing.

For programs where there may be challenging immunotoxicity considerations, we can work with you to develop the bespoke analytical methods that may be required.

Requirements for Immunology Testing

Assessment of immune endpoints will be required for any therapeutic which is either designed to modulate immune function or belongs to a class of compounds with known immunomodulatory potential.

  • Therapeutics with Defined Pharmacology

    For therapeutics where the pharmacology is defined, specific endpoints can be designed. This is especially relevant for monoclonal antibodies or other therapeutics which interact with targets that have known immunomodulatory functions. Assessments may span in vivo immunology testing, such as immunophenotyping panels, to characterize changes in the phenotype of key immune cell populations, measurements of receptor occupancy, and in vitro assessments of potential liabilities with approaches such as cytokine release assays and degranulation assays.

  • Prophylactic or Therapeutic Vaccine

    Immunology testing is also a requirement in the preclinical development of prophylactic or therapeutic vaccine programs were there is a need to demonstrate the exposition to the vaccine candidate by induction of and establishment of appropriate and/or humoral and cell-based immune responses.

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We offer immunology testing support beyond IND/CTA enabling studies. Our clinical support covers the full range of modalities from small molecules, through recombinant proteins, and to cell and gene therapies. We can support the development and validation of clinical immunological assays compliant with current regulatory expectations, flow cytometry sample analysis on a global scale, and support biomarker strategies.

Application of Immunological Assays During Drug Development

The increase in knowledge of immunomodulatory mechanisms, and our ability to manipulate them, has led to significant therapeutic breakthroughs against a variety of diseases. This has been most evident in the successes of immunomodulatory approaches in oncology, as well as in other pathologies with a critical immune system component. The discovery and development of immunomodulatory compounds requires specific knowledge and laboratory investigations at every stage.

Immunology Assays at the Discovery Stage

During discovery, the knowledge of molecular and cellular pathways controlling immune function is a prerequisite. It underlies the characterization of new therapeutic targets, screening assays for new compounds, and expediting the identification of optimum lead candidates.

Immunology Testing at the Safety Assessment Stage

When a therapy is designed to modulate immune system functions, specific safety concerns must be addressed. Important aspects of immunology testing include:

  • The distinction between the desired pharmacological response and exaggerated pharmacology
  • Any unanticipated immune modulation

This focus on immunotoxicity is important because the immune system can show switch kinetics, where dosing above a certain level may show acute changes and significant adverse events, such as cytokine release syndrome (the ‘cytokine storm’). Given the known differences in immune systems between safety species and humans, applying immunology testing techniques, such as the cytokine release assay, are a key part of safety assessment.


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Immunotoxicity encompasses a large variety of effects, such as decreased host resistance to infections, cancers for immunosuppressive compounds and increased risk of autoimmune disease, or hypersensitivity for immune activating agents.

The ICH S8 guideline for human pharmaceuticals with immunomodulatory actions recommends a weight-of-evidence approach to assess potential immunotoxicity risk. Additional immunotoxicity endpoints reflecting the mechanism of action of the compound should be included within study designs. Appropriate readouts of immunology testing can be very diverse, including:

  • Immunophenotyping by flow cytometry
  • Cytokine measurements in cell supernatants or plasma
  • In vitro immunology testing to assess immune cell functions
  • TDAR assay (T cell dependent antibody response)

Our knowledge and expertise can help you design the appropriate studies and immunology assays needed to support the safety assessment of immunomodulating agents.

How Can We Support You?

Immunotoxicity Testing at the Clinical Stage

In the clinical phase, immunology assays become critical for almost all advanced therapeutics – from monoclonal antibodies (mAbs) for oncology, through vaccine programs, as well as gene and cell therapies. Clinical immunological assays will be required for any therapeutic that might trigger an immune response to ensure the response doesn’t compromise patient safety.

The following immunology testing investigations use different techniques to assess potential immunogenicity of therapeutic candidates:

  • Flow cytometry for PK/PD
  • ELISpot, to evaluate cellular immune response
  • Multiplex cytokine analyses

Our expertise can help you choose the right tools to analyze samples from multicenter clinical trials.

Different Immunotoxicity Endpoints

Since the immune system is so complex, multiple endpoints are often required to assess the potential immunotoxicity of a compound. For these programs, data from immunophenotyping, receptor occupancy, TDAR, and immune biomarkers must be considered holistically to ensure reliable interpretation.

There is also a requirement to integrate immunology assays with other bioanalytical analyses and their interpretation (e.g., relating receptor occupancy and TK/PK).

Our expertise can help you select and design the correct mix of endpoints and analytical approaches. Our immunologists work together with our toxicology team and other experts to ensure you get high-quality data and interpretation to drive your program forward.

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Frequently Asked Questions (FAQs) About Immunology Testing

  • How does immunology testing change based on therapeutic area?

    Immunology testing assessments are largely driven by the mode of action of a drug. A general risk of immunomodulatory therapeutics is exaggerated pharmacology – adverse events related to the mode of action of the drug. This requires close consideration of basic mode of action and data from in vitro and in vivo efficacy studies to ensure that the appropriate endpoints are assessed in the safety phase to determine any immunotoxicity events.

  • How can I measure immune response?

    The immune system is a complex physiological network of cells and organs. A full assessment requires diverse approaches and may include functional immunology assays, such as the T cell dependent antibody response (TDAR), and detailed characterization of cell populations from the blood and lymphoid organs using flow cytometry.

  • Are all immunology assays required on all programs?

    No; even though some immunology assays will be common to many programs, the exact set of immunological assays and their specification is tailored to the given drug.

  • What immunology testing platforms should I choose?

    During immunology testing, choosing a platform is a secondary consideration to the assessed attribute. For example, while flow cytometry is the most common technique for assessing the phenotype of immune cells, it may be necessary in some cases to apply other techniques, such as immunohistochemistry, to assess the phenotype of immune cells within non-lymphoid organs.

  • What regulatory guidance is available for immunology testing?

    There is regulatory guidance from major authorities and ICH. A common element to the immunotoxicology guidance is the application of a risk-based approach – tailoring assessments to the specific potential safety liabilities of each drug by immunology testing.