Intertek Pharmaceutical Services
 
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Intertek Alta Immunochemistry

Alta's Immunochemistry Services Group has experience in the development and validation of quantitative immunoassays for the measurement of macromolecules, for example: therapeutic drugs, synthetic peptides, humanized monoclonal antibodies, chimerics, growth factors, hormones, cytokines, and biomarkers. We work 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.

The Group is also very experienced in the development and validation of immunogenicity assays . The challenge of developing and validating cell-based assays for neutralizing antibody evaluation is also a strength of Alta's immunochemistry lab. Each client, each assay, each compound, is evaluated on an individual basis with regards to the approach to development and the approach to providing a comprehensive and scientifically sound validation.

Alta has a history of keeping pace with the requirements of the industry and the expectations of the FDA, to assure reliable assay development and validation, and has constantly made every effort to improve the Quality Control Systems to provide clients with reliable and robust assays for both preclinical and clinical studies.

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