Smithers, a bioanalytical contract research organization (CRO), has the ability to develop, qualify and validate single and multiplex assays in the most difficult matrices (CSF), synovial fluid, aqueous/vitreous humor, etc) to as low as femtogram sensitivities using various platforms.
Platforms include Singulex Errena and Quanterix Simoa, ELISA, alpha-LISA and MSD.
Smithers is a GLP and CLIA laboratory.
Fit-for-Purpose Biomarker Test Development and Validation
Platforms include Singulex Errena and Quanterix Simoa, ELISA, alpha-LISA and MSD.
Smithers is a GLP and CLIA laboratory.
Fit-for-Purpose Biomarker Test Development and Validation
Biomarker assay development and validation at Smithers follows the “Fit-for-Purpose” concept described by Lee et al. (2006)
Biomarker assay capabilities include:
- ELISA (single analyte)
- Meso Scale Discovery (single and multiple analytes)
- Singulex (Ultra-sensitive, single analytes)
- Quanterix Simoa HD-1™
Biomarker Experience
Cytokines
- Chemokines
- Interferons
- Interleukins
- Colony Stimulating Factors
Disease-focused biomarkers
- Oncology (AKT, pAKT, vEGF, bFGF, EGFR)
- Neurology (Abeta, APP, Tau, pTau)
- Auto-immune (CRP, dsDNA, ANA)
- Metabolic Disorders (Glucagon, IGF-1, pancreastatin, hGH)
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:
- Data regression, raw data storage are within Watson LIMS™
- Can optimize standard curve as needed
- Do not need 12 point curve
- During development can have multiple curves on the plate
- Greater sample capacity
- Can select one of three output as raw data source
- Full chain of custody for samples
- Immunogenicity Assays
- Bioassays
- Biomarkers Test Development
- Generic PK/TK Assay to Support Development of Large Molecules and Biosimilars
- Immuno-Oncology Assays
- Monoclonal/Polyclonal Antibody Assays
- CAR-T and TCR Assays For Cellular Therapeutic Support
- Bi-specific antibodies
- Biobetters and Biosimilars
- Bioanalytical Testing Instrumentation
- Lab Automation Equipment