Bio-analysis

TetraQ has strong GLP bioanalytical capabilities and can analyse large volumes of samples generated from studies conducted in-house or from externally conducted studies, including clinical trials. 

Services 

  • Bioanalytical Method Development and Validation including LC-MS/MS, HPLC, GC-MS, GC-FID, FT-IR, ELISA, ELISpot and PAMPA assays
  • Sample analysis of compounds and metabolites in human and animal samples
  • Clinical trial samples analysis and pharmacokinetic studies
  • In vitro and in vivo ADME bioavailability and pharmacokinetic studies
  • Toxicokinetic studies
  • Biodistribution studies
  • Metabolic Screening & Profiling studies
  • Biological Stability Testing

Analyses

  • HPLC Analysis
  • LC-MS/MS Analysis
  • GC-MS Analysis
  • ELISA Analysis
  • HaHa Analysis
  • CYP450 Analyses
  • Plasma Protein Binding
  • Radioisotope Analysis

TetraQ’s laboratories hold ISO 17025-2005 (R&D) accreditation and GLP Recognition according to the OECD Guidelines and operates state-of-the-art instruments and technologies.

Preclinical Studies
TetraQ provides GLP ADME services including in vitro metabolism studies in hepatocytes, expressed CYP's liver microsomes or cytosol, as well as in vivo pharmacokinetic studies in rodents. Other ADME services available at TetraQ include PAMPA assays, plasma protein binding, plasma and tissue homogenate stability, biodistribution studies and pharmacokinetic parameter estimation.

Bioanalytical Methods: Area of Specialist Expertise
TetraQ is highly experienced in developing bioanalytical methods of novel compounds in a range of biological matrices using a variety of methods including robotic SPE - API3200 LC-MS/MS, HPLC-MS/MS, HPLC with UV or fluorescence detection, GC-MS, GC-FID and ELISA methods. TetraQ has a very extensive library of validated bioanalytical methods.

The bioanalytical methods are "fit for purpose" from screening assays right through to comphrensive full validation required by regulatory agencies such as the FDA, EMA and the TGA. The level of method validation required depends upon your stage of drug development.