Lab Services

Bioanalysis

The advanced LC-MS/MS (liquid chromatography-tandem mass spectrometry) instrument facilitates rapid development of methods for analyzing drugs and their metabolites in biological fluids, such as blood, plasma, serum, urine, and tissue extracts, with high sensitivity, precision, specificity, and dynamic range. We offer the following bioanalysis services:

  • Development of bioanalytical methods to support fit-for-purpose studies using various techniques (protein precipitation, LLE, SPE).
  • Method validation conforming to US FDA, EMA, and ICH guidelines.
  • Quantitation of test compounds and metabolites in biological samples (plasma, blood, urine, bile, tissues). 

In vitro ADME

We offer a range of in vitro drug metabolism and transporter studies typically performed for candidate optimization and regulatory filing:

  • In vitro metabolisms in multiple species using subcellular fractions and hepatocytes
  • Metabolite ID and profiling of a drug candidate using QTOF and QTRAP LC-MS/MS
  • Protein binding (plasma and microsomes) and blood partitioning determination
  • In vitro permeability and transport studies using polarized MDCK-II, LLC-PK1, or Caco-2 cells and P-gp and BCRP transporter overexpressed or Caco-2 cells
  • Drug-drug interaction (DDI) liability assessments
    • Reaction phenotyping (CYP and non-CYP and drug transporters)
    • Enzymes (CYP450 and UGTs) reversible and time-dependent inhibition
    • Drug transporter (P-gp, BCRP and OATP1B1/B3) inhibition studies

For more information on our services, please contact us.