Quantitative ligand-binding assays (immunoassays), qualitative immunogenicity assessments, cell-based assays for neutralizing antibodies and biomarker assays in combination with toxicokinetics and clinical pharmacokinetics for large molecules.
Intertek Pharmaceutical Services Immunochemistry offers extensive expertise in the development and validation of quantitative ligand-binding assays (immunoassays) for use in PK (pharmacokinetic) and TK (toxicokinetic) studies including immunogenicity and biomarker studies for novel biologics, biosimilars and a wide range of macromolecules that include synthetic peptides, humanized monoclonal antibodies, chimerics, various growth factors, hormones, cytokines and biomarkers.
Industry-leading scientific expertise includes developing and validating proprietary assays, implementing and validating existing methods, optimizing methods then validating, and validating existing immunoassay kits (ELISA and ECL platforms). The laboratory is FDA inspected and GLP-compliant.
This GLP laboratory is recognized as one of the leading immunochemistry laboratories in the world. Founded in 1999, the research facility is located in San Diego, California. The Senior Laboratory Director is Dominique Gouty.
- Biomarker Assays and Validation
- Cell-Based Neutralization Assays
- Immunogenicity Assays
- Ligand-Binding Assays
- Clinical and Preclinical Pharmacokinetics
Related Services for Macromolecules
Related Services for Small Molecules
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