Immunogenicity Testing and Predictions

Our Immunogenicity Platform includes

  • Anti-drug antibody (ADA) detection and characterisation
    • Multi-tiered approach:  screening – conformation and Titration
    • Additional characterisation: isotype and subclass differentiation
  • Innovative platform: Affinity characterisation of ADA directly in matrix
  • Neutralising capacities of ADAs
    • Bethesda assay
    • Pseudovirus neutralisation assays
  • In vitro models for immunogenicity prediction of therapeutic proteins
    • Activation/maturation assays of moDCs
    • Cytokine release assay (CRA)
    • Complement activation assay
    • DC-T Cell co-culture assay
    • T Cell proliferation assay
    • T Cell activation assay

Understanding immune response to drugs

Immunogenicity is an important aspect of biologic drug development as it can impact both the efficacy and safety of the drug. When the immune system recognises a biologic drug as a foreign substance, it may generate an immune response that leads to the production of antibodies. These antibodies can neutralise the drug, leading to a reduced therapeutic effect or cause adverse effects. The impact of immunogenicity on drug development and patient safety can be very significant, as it may result in drug failures, increased healthcare costs, and patient harm.

Understanding and predicting the potential of a biologic drug to induce an immune response is therefore a fundamental part of drug development. Immunogenicity testing can help researchers and clinicians understand how the immune system will react to a treatment, and can be used to identify potential safety concerns or optimise dosing regimens. The interplay between the adaptive and innate immune responses is complex, and the characterisation of immune responses against a drug requires a thorough understanding of the immune system and its components. Each project requires the selection of appropriate assays and a specific assay strategy, as many different drug and disease specific aspects need to be taken into account when investigating adverse immune reactions.

State-of-the-art analysis of immunogenicity

We offer a range of immunogenicity testing and prediction services to support drug development and clinical trials, as well as post-approval as a routine monitoring parameter. Our experienced team of scientists understands the complex mechanisms underlying the immunogenicity of biologic drugs and can provide comprehensive and meaningful analyses of immune responses. This includes detection and characterisation of anti-drug antibodies (ADA) using a multi-tiered approach (screening-confirmation-titration), isotype and subclass differentiation, neutralisation capacity and an innovative platform for the evaluation of apparent affinities of ADA.

Contact us today to learn more about how our immunogenicity testing services can support your drug development programme and help to ensure the safety and efficacy of your biologic drugs.

Services Overview