Caprion

Finding proteins that hit the mark

Fit-for-purpose Assays

Caprion uses Multiple Reaction Monitoring (MRM) mass spectrometry to develop robust, quantitative assays for non-clinical and clinical use. Fit-for-purpose assay development often follows a biomarker discovery study, but can also be applied to proteins of interest from other sources. Because the fit-for-purpose approach includes assay qualification and/or validation, it is usually applied once the number of proteins of interest have been narrowed from 100s to 10s. MRM assays are typically antibody-free, can be rapidly and easily multiplexed, and provide high specificity and sensitivity. For low abundance targets, antibody enrichment can also be combined with MRM to further enhance assay sensitivity. Our experienced team uses a tiered approach to develop fit-for-purposes assays that meet customer and regulatory requirements.

Applications

Qualification and validation of biomarker assays for use as primary/secondary endpoints or as exploratory markers in regulated environments

  • Pharmacodynamics
  • Monitoring of drug efficacy and response
  • Patient selection and stratification
  • Surrogate endpoints
  • Diagnosis and disease monitoring

Benefits of Caprion’s Fit-for-Purpose Assays

Multiplexed, antibody-free assays can be rapidly developed for biomarker verification, validation, and application in support of non-clinical and clinical studies

  • Customized biomarker assays to meet evolving requirements throughout the drug development lifecycle
  • Highly specific, sensitive mass-spectrometry based assays
  • Absolute quantitation
  • GLP capability with QA environment

 

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