Bioanalysis

Areas of bioanalytical expertise include:

• Immunoassays
• Immunochemistry
• Quantitative Ligand Binding Assays
• Cell Based Assays
• Biomarker Assays
• Multiplex Assays
• Detection of Antibodies to Specific Compounds

• Immunogenicity Assay Development, Validation
• Cell-based Assays for Neutralizing Antibody Evaluation Development, Validation
• Analysis and Characterization of:
  • Proteins, Macromolecules
  • Peptides, Oligonucleotides
• Research, Development and Manufacture of Macromolecule Therapeutics
• Inorganic Bio-analysis

Intertek provides experience in the development and validation of quantitative immunoassays for the measurement of macromolecules, including:

• Therapeutic drugs
• Synthetic peptides
• Humanized monoclonal antibodies
• Chimerics
• Growth Factors

• Hormones
• Cytokines
• Biomarkers
• Immunochemistry Services Overview
• GLP Compliant ECL Bioanalytical Methods

Intertek works closely with sponsors to determine the needs of the assay, regulatory requirements, turn around times, report requirements, and make every effort to work within their budgetary restrictions. Each client, assay and compound are evaluated on an individual basis with regards to the approach to development and providing a comprehensive and scientifically sound validation.

Intertek has a proven history of keeping pace with the requirements of the industry and the expectations of regulatory agencies like the FDA. The labs provide reliable assay development and validation, with professional Quality Control Systems to provide clients with reliable and robust assays for both preclinical and clinical studies.