Bioanalytical Services

GLP and GCP bioanalytical services supporting all phases of drug development and non-GLP rapid discovery phase bioanalysis via state of the art facilities

Intertek has over 20 years experience in conducting regulated bioanalytical studies supporting the development of pharmaceuticals, biopharmaceuticals, vaccines and biosimilars. Expert bioanalysis support for both small molecule drugs and biologics is provided through our global network of state-of-the-art, GLP-compliant laboratories located in California, US (San Diego) and in the UK (Manchester).

Capabilities include proprietary method development, validation, method transfer, high throughput sample analysis and pharmacokinetic and toxicokinetic support, combined with automated data capture and reporting system. Clinical sample management services are provided for collection and shipment of samples from clinical study sites.

Recognizing the critical role bioanalysis plays in drug development, our mission is to consistently deliver accurate and reliable data that is subject to rigorous scientific and regulatory review, ensuring the success of your discovery, preclinical and clinical programs.  

Bioanalytical Services for Preclinical and Clinical Studies:

• Method Development
• Method Validation
• Lead Optimization Studies
• Pharmacokinetic (PK) Analysis
• Bioavailability Studies 
• Bioequivalence Studies
• Dose Formulation Analysis
• Clinical Kit Preparation, Sample Handling and Management
• GCP Bioanalytical Services
• Bioanalytical Technologies including Liquid Chromatography - Mass Spectrometry, Inductively Coupled Plasma – Mass Spectrometry, Capillary Electrophoresis and Nuclear Magnetic Resonance Spectroscopy
• Bioanalysis of PEGylated and other Polymer-Linked Drug Assays
• Metals And Elemental Bioanalysis by ICP-MS

Small Molecule Bioanalytical Services:

• Quantitative Bioanalytical LC-MS/MS
• Rapid Discovery Phase Bioanalysis
• Tissue Bioanalysis including expertise in Ocular Tissue Bioanalysis 

Large Molecule Bioanalytical Services:

Intertek is a world leading provider of immunochemistry and biomarker services for bioanalytical studies supporting the preclinical and clinical development of protein based therapeutics and other biologic medicines.

• Immunochemistry Services
• Quantitative Immunoassays
• Immunogenicity Assays
• Biomarkers Assays
• Cell-Based Neutralization Assays
• Ligand-Binding Assays