Immunogenicity Centre of Excellence

Immunogenicity bioanalysis solutions for pre-clinical and clinical assessments

Over 70+ dedicated scientists developing assays at one of Europe’s largest labs offer immunogenicity services that can be tailored to your needs.

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Anti-drug antibody (ADA) and neutralisation (NAb) assays

Immune responses to therapeutic products have the potential to affect Pharmacokinetics (PK), Pharmacodynamics (PD), safety and efficacy.

Assessment of a biotherapeutics ability to produce an immune response requires the development of customised immunoassays following a tiered approach. With a specialised team of scientists and regulatory project managers, the Immunogenicity Centre Excellence, Cambridge (Fordham), has a wealth of experience in developing and validating sensitive, specific, selective and drug/target tolerant ADA and NAbs assays to support non-clinical and clinical immunogenicity up to Phase IV post-marketing surveillance. All validation is performed to GCP or GLP standards in line with current regulations (FDA and/or EMA).

Developed and validated assays

Our expert team have supported a wide range of drug development programs for biotherapeutics, including:

  • Monoclonal Antibodies (mAbs)
  • Antibody fragments (Fab, nanobodies, domain antibodies)
  • Antibody Drug Conjugates (ADCs)
  • Bispecifics (including multi-domain characteristaion)

Projects we have supported

We have supported a wide range of drug development programs for biotherapeutics, including:

  • Proteins: including multi-domain
  • Peptides
  • Biosimilars
  • Adeno-associated Viruses (AAVs): gene therapy, both for pre-treatment screening and to monitor immune responses during trials.

Our team of dedicated technical specialists, determine the most appropriate analytical tools to develop and validate high quality assays. We have proven trouble-shooting experience in an extensive range of techniques (including acid dissociation, ACE and SPEAD, isotyping, cell-based and ligand binding nAbs) and routinely solve analytical challenges in order to meet assay requirements (e.g. drug and target tolerance).

Scientific expertise

Our team includes active members of the European Immunogenicity Platform (EIP) and European Bioanalysis Forum (EBF) including participation in working groups. All staff are encouraged to attend and present at conferences. In addition, we have an extensive internal training programme to ensure scientists have an overall understanding of the reasons that immunogenicity assessment is required, the regulations and analytical challenges and solutions.

Follow the below links to articles featured in Bioanalysis Zone written by our experts:

Regulation and standardisation of immunogenicity assessments: a CRO’s perspective

Immunogenicity methods and strategies