Immunochemistry Services
Immunochemistry contract laboratory services, including development, validation and analysis supporting toxicokinetics (TK), pharmacokinetics (PK), immunogenicity, and biomarker studies, with the latest high-spec technologies
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. In support of clinical and preclinical studies, our scientists have extensive experience developing, validating, and implementing quantitative or qualitative Good Laboratory Practice (GLP) / non-GLP immunoassays.
Our technology and industry-leading immunochemistry expertise include developing and validating proprietary assays, implementing, and validating existing methods, optimizing methods then validating, and also validating existing immunoassay kits (Simoa, ELISA and ECL platforms).
With almost 30 years’ experience in large molecule bioanalysis, our experts are thought leaders in the global immunochemistry community with a strong knowledge of regulatory guidance and scientific background. Our GLP compliant laboratory in Manchester, UK, is 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 lab and 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.
Immunochemistry Lab Services
- Immunoassays
- Biomarker Assays
- Cell-Based Neutralization Assays
- Immunogenicity Assays
- Ligand-Binding Assays
Related Services for Large Molecules
Related Services for Small Molecules
Discover our services
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Learn More - Overcoming Challenges in the Development and Validation of Biologics and Small Molecules in Ocular Tissues
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Learn more - Impact of Recent Changes to FDA Immunogenicity Draft Guidance
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Learn more - Additional webinars
NEW! Discover our Audit Live Tool for direct access to our scheduled audits
EVENT: 2nd Annual Inhaled and Nasal Biologics/DNA Forum - REGISTRATION IS LIVE
VIDEO:EXTRACTABLES/LEACHABLES LAB TOUR - Request access
WORKSHOP: How to Build an Inhaler (RDD 2023)
PRESENTATION:E&L Strategies (3rd Annual Extractables & Leachables Conference)
TALK: Medical Device Extractables & Leachables Studies
TALK: ID and sensitivity issues during E&L studies
ARTICLE: Glycosylation Analytical Approaches for Antibody Therapeutics
APP NOTE: Rapid Determination of Low/Trace Level Benzene in Pharmaceutical Excipients and Finished Products
ARTICLE: Importance of Aligning a Pharma Audit Scope with the Correct Standard
TALK: mRNA Analytics: Capping Efficiency, Sequencing, Poly-A Tail, dsRNA
RESOURCES
Brochure Downloads:
Bioanalysis Services Brochure
Trace Metals Bioanalysis and Biomarker Quantification
White Paper Downloads:
Biomarker Development and Validation
Bioanalysis Of Pegylated Species In Human Plasma By NMR