Immunochemistry services including development, validation and analysis supporting toxicokinetics (TK), pharmacokinetics (PK), immunogenicity and biomarker studies
Immunochemistry, or large molecule bioanalysis, is necessary to gain data on product efficacy, safety, disease state or mechanism of action, which will allow you to make informed and important decisions during biologic drug development.
Our immunochemistry experts provide this support through immunoassays, ligand binding assays supporting toxicokinetics (TK) and pharmacokinetics (PK) studies, immunogenicity and biomarker studies. Our scientists have extensive experience in the development, validation, and quantitative or qualitative Good Laboratory Practice (GLP)/non-GLP immunoassays in support of clinical and preclinical studies.
Our industry-leading immunochemistry expertise includes developing and validating proprietary assays, implementing and validating existing methods, optimizing methods then validating, and also validating existing immunoassay kits (ELISA and ECL platforms).
Founded in 1999, our US center of excellence is located in San Diego, California. The facility is GLP compliant and inspected by the FDA. Our GLP European facility is located in Manchester, UK.
With over 20 years’ experience in large molecule bioanalysis, our experts are thought leaders in the immunochemistry community with a strong knowledge of the regulatory guidance and scientific background. Our GLP compliant laboratories are equipped with the latest technology for immunoassay development such as quantitative ligand or receptor binding assays or immunoassays for use in pharmacokinetic (PK) and toxicokinetic (TK) studies. Our scientists regularly work with clients from all around the world, on a range of product types including monoclonal antibodies, antibodies-drug conjugates, growth factors, hormones and cytokines.