Biomarkers

Experienced in developing, qualifying and validating biomarker assays

Drug Candidate Evaluation
Product Development
Clinical Services
Applications & Solutions

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