Drug Analysis For NCE & Biologics

Drug Analysis For NCE & Biologics

Our GLP-certified drug analysis laboratories can implement or extend any existing assay for parent drug and their eventual metabolites, active or inactive e.g. antiviral & anticancer nucleoside derivatives . This expertise concerns NCE as well as biologics with immunoanalysis , chemical analysis as well as molecular biology solutions.

Interestingly, our large number of collaborations with chemists and biochemists permits us to handle and resolve the difficulties encountered (i.e.: in vitro interconversion between pro-drugs and active metabolites, poorly soluble drugs, unstable compounds, endogenous compound) and lead to success your projects.

At Bertin Pharma, we may perform:

  • development & validation of drug-analytical methods including tailor-made methods addressed to fussy assays and methodology applied to DBS (Dry Blood Spot)
  • improvement & validation of drug analytical methods
  • transfer technology of drug analytical methods
  • routine drug analysis using:
    • > automated, on-line & tailor-made solid phase extraction (including restricted Access Media & Turbulent Flow Chromatography) & staggered
    • > HPLC-MS /MS
    • > HPLC with UV, fluorescence & radioactive detection and mass spectrometry detection
    • > MALDI-TOF
    • > radioisotope determination in biological specimens
    • > immunoassays (radio- and enzymo-) and binding- & cell-based assays
    • > competitive hybridization and other molecular biology assays such as qPCR & RT-qPCR

Through these skills, Bertin Pharma offers a comprehensive & integrated platform allowing pioneer and state of the art expertise related to therapeutic proteins, gene therapy and cell therapy. Unwanted immunogenicity is often deleterious with a neutralization of pharmacological effects of therapeutic proteins in parallel of the emergence of Anti-Drug Antibodies (ADA) and Bertin Pharma explores this issue using these different tools and others.