Immunogenicity Assays

Evaluating the immune response in preclinical models through clinical samples, immunogenicity testing is mandatory throughout the development process. Whether you’re developing a vaccine, biologic or gene therapy, immunogenicity testing measures the antibodies generated against your drug, allowing you to determine efficacy and safety with confidence. Our experienced team applies a fit-for-purpose approach to your immunogenicity testing program that accounts for your drug’s MOA, regulatory requirements, and your overall program needs.

While selected assays may vary by therapeutic, step-by-step immunogenicity testing cascade is generally as follows:

The step-by-step immunogenicity testing cascade.


Immunogenicity Testing Capacity and Capabilities

Given the need to perform immunogenicity testing throughout the development cycle of your therapeutic, you will want to ensure you have access to test facilities where and when you need them. With 12 sites across North America and Europe, Charles River can accommodate studies on your timelines using a variety of platform technologies, including:

  • Meso Scale Discovery (MSD)/Electrochemiluminescence (ECL)
  • Flow cytometry
  • Gyrolab

Our team has the immunology expertise, drug development experience, and flexibility to create and execute the right testing program for your therapeutic. Consider the advantages of working with our specialists:

  • Breadth of immunogenicity assay types

    We’ll ensure immunogenicity testing is developed appropriately, utilizing a variety of methods as necessary. Our personalized approach to immunogenicity testing ensures selected assays are sensitive, specific and robust, so that the safety endpoint can be analyzed with confidence.

    In addition to a standard bridging or anti-species detection format, we have extensive experience utilizing additional assay formats (see the list below) when presented with assay challenges such as high background or insufficient drug tolerance levels:

    • ACE: affinity capture elution
    • Acid dissociation
    • SPEAD: Solid phase extraction with acid dissociation
  • Ability to adapt ADA strategies

    In our custom approach to immunogenicity testing, we determine your needs based on the stage of your work. In the preclinical phase, we will suggest whether your program requires anti-drug antibody (ADA) analysis is required to elucidate PK, PD, or pathology data interpretation. In the clinical phase, ADA studies may be required to monitor patient safety.

    Formonoclonal Antibodies drug, we need to address their safety concerns on the immune system by running immunogenicity testing, as explain on this webinar.

    Assessing the Safety and Immunotoxicity of Monoclonal Antibodies Webinar

    How to address the safety concerns of mAbs by immunogenicity testing, through ADA assay to nAb assay?
    Watch now

    Your novel therapy has unique requirements. In a risk-based approach to preclinical immunogenicity testing, we work with you to assess your study needs and develop the proper solution, from a fit-for-purpose qualification in low-risk scenarios to fully validated assays for higher risk programs.

    Using approaches ranging from single assays with a 0.1% or 1% false positive ratio, to multi-tiered analytical strategies characterizing the ADA response, we work with you to identify the best methods to support your project through the entirety of the drug development journey.

  • Neutralizing antibodies (nAb) assay specificities

    As per the FDA guidance, the impact of ADA on PK, PD, and safety may correlate more with the nAb activity rather than ADA incidence, and therefore an assay to characterize the neutralizing activity of the detected ADAs is critical for performing immunogenicity testing in clinical studies.

    We can help guide your strategies to develop, validate, and implement immunogenicity assays to detect neutralizing activity, which can range from cell-based bioassays to competitive ligand binding assay (LBA) formats to enzymatic assays, depending on the mechanism of action or known standard approach for the drug class.

    Given the complexity and challenges involved in developing and validating nAb assays, especially bioassay formats, having the expertise and experience from a reputable laboratory can make all the difference in the clinical development of your drug.

  • Statistical support for immunogenicity testing cut point calculation

    Interpreting the guidance requirements for the statistical determination of ADA assay and nAb assay cut points can be challenging. Dedicated statisticians are on hand with the expertise in immunogenicity testing and standard statistical approaches in compliance with the EMA and regulatory guidance and current literature recommendations. The team is also familiar with robust alternative approaches to address your specific requirements, complex experimental designs, and challenges like preexisting reactivity.
    Learn more

  • Immunogenicity testing: an efficacy measure for vaccines

    Available in qualitative and quantitative assay formats, vaccine immunogenicity assays can be developed to confirm dosing and monitor efficacy.

    SA-Scientific Poster WRIB 2020 DE LARICHAUDY J Immunogenicity Vaccine.pdf

    Immunogenicity Assays & Vaccine Development

    How can immunogenicity testing can accelerate vaccine development? A quantitative ELISA method combines assets of different approaches to give reliable results on vaccine efficacy with minimal time & effort.
    View the Poster

    Immunogenicity testing allows you to establish the immune response to your compounds at the anti-drug antibody (ADA assay) or neutralizing antibody (nAb assay) level. At Charles River, you’ll find a dedicated multidisciplinary team of immunologists, statisticians and drug development experts who can help you devise the best strategy for your therapeutic so you can move forward to IND and monitor your drug in clinic.

    For further immunogenicity support, see our monoclonal and polyclonal antibody production services to support preclinical and clinical development of immunogenicity assays.

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Frequently Asked Questions (FAQs) about Immunogenicity Testing