Biomarker assay development and validation at Smithers follows the “Fit-for-Purpose” concept described by Lee et al. (2006)
Biomarker assay capabilities include:
Ultra-sensitive immunoassays (those in sub picomolar range), provide an ability to accurately and precisely quantify low levels of biomarkers as well as bio therapeutics (PK samples), with robustness .
The Singulex system couples proprietary digital Single Molecule Counting (SMC™) technology with microparticle-based immunoassays to provide higher sensitivity over traditional immunoassays, such as ELISA platforms. Smithers, a GLP and CLIA-certified laboratory has developed and validated assays and analyzed samples for PK and biomarkers on the Singulex ERENNA® platform.
Smithers has added the Simoa HD-1 Analyzer to its Bioanalytical Laboratory. With this addition, the company augments its existing stable of lab instrumentation, allowing for increased efficiency and capacity for testing related to the development and validation of immunoassays that are used during the development of biologics. The Simoa HD-1 Analyzer is a fully-automated instrument for running immunoassays using Quanterix’ proprietary single molecule array, or Simoa, platform.
We have fully validated the Singulex ERENNA® and the interface to the Watson LIMS™ in a GLP environment.
This has the following advantages: