Immunogenicity

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

LGC Immunogenicity

Our Immunogenicity Centre of Excellence is built upon a wealth of experience in the development and validation of sensitive, specific, selective and drug tolerant assays to measure anti-drug antibody (ADA) responses to therapeutic protein products.

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

Our services can be adapted to your specific requirements:

  • Variety of analytical platforms (Meso Scale Discovery, AlphaLISA, ELISA, Gyrolab), and use a range of approaches to increase drugtolerance e.g. acid disassociation, ACE, SPEAD and BEAD.
  • Expertise in characterisation of multi-domain specific immunogenicity responses and isotyping.
  • Experienced method development team that develop assays for screening, confirmatory, titre and nAbs (including cell-based and competitive ligand binding assays).
  • Key method development decisions and analytical data are summarised and shared with our customers in real time.
  • Independent Principal Scientist team to ensure the suitability of the method meets regulatory requirements.

 Quality & regulatory guidance

  • Validation performed to GCP or GLP standards in line with current regulations (FDA and/or EMA).
  • Full risk assessment strategy implemented when new guidance issued (e.g. FDA 2019 Assay development and validation for immunogenicity testing of therapeutic protein products).
  • Full review of validation reports of potential transfer assays with advice provided on alignment with current guidance.

For more information about our Immunogenicity services download our fact sheet or contact us to discuss your requirements.