Immunogenicity Centre of Excellence
Anti-drug antibody (ADA) and neutralisation (nAbs) 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.
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.
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LGC have supported a wide range of drug development programs for biotherapeutics, including:
- Monoclonal Antibodies (mAbs)
- Antibody fragments (Fab, nanobody, domain antibodies)
- Antibody Drug Conjugates (ADCs)
- Proteins: including mutli-domain
- Bispecifics (including mutli-domain characteristaion)
- Adeno-associated Viruses (AAVs): gene therapy
Benefitting from gold-standard technologies (e.g., MSD, AlphaLISA, Gyrolab and Flow cytometry, with back-up instruments) our expert technical specialists, will determine the most appropriate analytical tools to develop and validate high quality assays. With proven trouble-shooting experience in an extensive range of techniques (including acid dissociation, ACE and SPEAD, isotyping, cell-based and ligand binding nAbs) we routinely solve analytical challenges in order to meet assay requirements (e.g. drug and target tolerance).
Communication and quality
- Key method development decisions and analytical data are summarised and shared with customers in real time
- In-house statistical analyses expertise
- Independent Principal Scientist reviews ensure that only suitable assays progress to validation and that validated methods meet regulatory requirements
- Validation performed to GCP or GLP standards in line with current regulations (FDA and/or EMA).
- Full risk review and Gap analysis following changes to Guidelines (e.g. FDA 2019, Assay development and validation for immunogenicity testing of therapeutic protein products)
- Immunogenicity data processed using 21 CFR compliance and validated software
- Routine use of Plan View to monitor capacity, ensure flexibility and avoid bottlenecks
- Our study reports are prepared and published in align with regulatory guidelines and expected format with the help of independent report writing team