Biomarkers

Experienced in developing, qualifying and validating biomarker assays

Drug Candidate Evaluation
Product Development
Clinical Services
Central Laboratories and Testing

Biomarkers

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.

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.

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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

Molecule Types

Platforms

Key Experiments

Reagents

  • Cytokines
  • Proteins
  • Enzyme activity assays
  • Small molecules
  • etc.

 

 

 

  • LC-MS/MS,
  • ICP-MS
  • SimoaTM
  • Ella
  • Luminex
  • ELISA
  • MSD

 

 

 

 

  • Method Development
  • Validation
  • Precision/ Reproducibility
  • Parallelism
  • Sensitivity/ Range
  • Stability and Sample Collection
  • Specificity and interferences
  • Quality Controls (longitudinal and intra-run)
  • Commercially available assays 
  • Home brewed assays

 

 

 

 

 

 

Therapeutically Focused Biomarkers

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  • Oncology
  • Infectious Diseases 
  • Cardiovascular
  • Endocrine
  • Neurosciences
  • Inflammation
  • Respiratory