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Immunogenicity (ADA) Testing

BioOutsource is a fully GLP and GCP compliant laboratory with extensive experience in the development and validation of analytical methods that form an essential component of an immunogenicity strategy. Our scientific staff can provide specialised consultancy on the overall conduct of an immunogenicity assessment, recommendations for assay designs and provide expert knowledge in the interpretation of the EMA and FDA Immunogenicity guidelines for validation and routine testing.

Immunogenicity Method Development

A typical immunogenicity assessment testing strategy is principally composed of two methods; a binding assay for the detection of binding antibodies and a cell based method for the detection of antibodies that neutralise the biological activity of the recombinant protein drug (neutralising anti-drug antibodies). Additional assays are required to determine the antibody type in any samples that are found to be positive. The basic binding anti-drug antibody assay and basic neutralising anti-drug antibody assay methods will undergo various adaptations, depending upon the number of individual samples that require assessment, to allow sample analysis to be performed in the tiered manner required by the regulators. Each of these methods will require development:

  • Screening Assay
  • Specificity Assay (or Confirmatory Assay)
  • Titre Assay (or quasi-quantitative Assay)

BioOutsource routinely performs binding assays and cell based potency assays for a wide range of different applications and offer a number of different analytical approaches to support your Immunogenicity testing requirements. We are currently developing a range of binding and neutralising ADA assays for biosimilars and we can apply this experience to provide expert advice on the assay designs that will provide the most sensitive assay designs or the provide that are capable of detecting antibodies with low affinity interactions. Our technical experts can recommend the most appropriate assay design choice for your project based upon preclinical/clinical phase budgetary requirements. Please select the hyperlink for more information on our binding assay development services or cell based potency & bioassay development services.

Immunogenicity Method Validation

BioOutsource performs fully GLP or GCP compliant method validation for binding and neutralising immunogenicity assays in accordance with specific EMA and FDA guidelines.

Both the FDA and EMA have issued specific guidance that details the factors that should be considered when conducting an Immunogenicity assessment. The EMAs Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins was published in 2007 and the FDA has published two guidelines, the first, Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins was published in December of 2009 and the second, Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products was issued more recently in February 2013. Specific Immunogenicity guidance for monoclonal antibodies has also been issued by the EMA in 2012: Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use

Our scientists have many years’ experience in the interpretation of these guidelines across each of the different assay types that are required, using different technology platforms for a variety of different recombinant protein products. We have standardised approaches for defining assay acceptance criteria and generating standard, specificity and floating cut points (cut point normalisation) and implement controls to minimise day to day variability. The detailed validation approach assesses assay sensitivity, selectivity, precision, robustness and stability.

Please contact us to find out more about our Immunogenicity assay development, validation and testing services.