Frontage’s Bioanalytical Team is highly experienced in developing, qualifying and validating Biomarker assays. We can apply traditional and newer ELISA platforms as well as ultra-sensitive detection capabilities (Quanterix Simoa) for quantitation in the femtogram/mL range including single and multiplex analysis in various disease categories.
Frontage was First to Offer Ultra-Sensitive Biomarker Quantification
Frontage Laboratories was the first CRO to validate multiple SimoaTM (Single Molecule Array) instruments in a GLP regulated environment. SimoaTM technology provides a novel and ultra-sensitive method for detecting and quantifying biomolecules in biological specimens at femtomolar concentrations. This very low-level detection is difficult or impossible to measure on other instrument platforms. The sensitivity of Quanterix Simoa analyzer makes it the instrument of choice for ultra-sensitive analysis of biomarkers.
Comprehensive Suite of Platforms
Our Biomarker assay platforms include both single plex and multiplex platforms in multiple matrices for use preclinical and clinical development programs. For exploratory and pre-clinical studies, our biomarker assays are useful to demonstrate the validity of a novel biomarker; for clinical trial studies, our assays can monitor the activity of a biopharmaceutical through analysis of therapeutic targets.
Board Range of Capabilities and Experience
Our biomarker scientists have developed and validated a large number of biomarker assays for pharmaceutical and biotech companies. We are proud to become a benchmark in the field and have a significant impact for our clients using our expertise and state-of-the-art technology to advance/monitor drug development. We have also published novel biomarker assays developed in-house to share our expertise with the industry. With the addition of new technologies such as ELLA and Luminex for biomarker analysis, we believe we will continue as a top-notch provider of biomarker assays in the years to come.
Areas of expertise include:
- Fit-for-purpose (FFP) and Exploratory Biomarkers
- Validation differences depending on the purpose of study and method categories
- Method validation to support Labelling Claims, Safety, Efficacy
- Significant endogenous levels of biomarker(s) of interest
- Parameters of validation and level of “compliance” (fit-for purpose), methodology and SOPs
- Define assay precision
- Variety of platforms available (based on the endogenous biomarker amount in the matrix
- Shared samples for many biomarkers
- Complexity around analysis of “multiplex” data
- Healthy vs Diseased performance differences
- Potentially different locations, labs, companies, instrumentation,
- Sample collection, processing and shipping inconsistencies
- Matrix selection & volumes
Frontage’s bioanalytical labs are compliant with internal standard operating procedures (SOP), Good Laboratory Practice (GLP) and CLIA Certified Laboratory. Our audit history with regulatory authorities and client inspections is virtually spotless. In addition to our stringent SOPs, Watson LIMS, e-Notebook and a validated freezer temperature monitoring system, central security alarm monitoring and 24-hour card controlled facility access ensures the highest levels of data integrity.