At Smithers, a trusted bioanalytical contract research organization (CRO), we specialize in the development, qualification, and validation of single and multiplex biomarker assays. Our expertise spans complex matrices such as cerebrospinal fluid (CSF), synovial fluid, and aqueous/vitreous humor, achieving femtogram sensitivities across a variety of advanced platforms.
Our team leverages the latest technologies to deliver precise, ultra-sensitive biomarker testing across multiple therapeutic areas. As a GLP and CLIA-certified laboratory, Smithers ensures the highest standards in assay development and validation. Our ultra-sensitive immunoassays are capable of accurately quantifying biomarkers and biotherapeutics, including pharmacokinetic (PK) samples, at sub-picomolar levels with unmatched precision.
Platforms
Advanced Technology for Accurate Results
Smithers ensures full validation and quality control of our assays. For example, our Singulex ERENNA ® platform integrates seamlessly with Watson LIMS™, offering the following benefits:
Our fit-for-purpose approach to assay development and validation guarantees that every solution is tailored to your specific research needs, ensuring the highest quality results at every stage of your project.
Frequently Asked Questions (FAQs)
What is a biomarker assay and how is it used in drug development?
- Biomarker assays detect and quantify biological markers that provide insights into the mechanism of action of a drug, its efficacy, and potential adverse effects. These assays help in evaluating drug performance and safety, essential for the development of new treatments.
How does Smithers ensure the accuracy and reliability of its biomarker assays?
- Smithers guarantees high standards through the development and validation of assays in GLP and CLIA-certified laboratories. We use advanced technologies like Single Molecule Counting (SMC™) and the Quanterix Simoa HD-1™ Analyzer, ensuring ultra-sensitive results and comprehensive quality control throughout the testing process.