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