Validated bioanalytical methods must be developed before the first preclinical pharmacokinetic data can ever be obtained from animals. These are the same methods used in IND-enabling, GLP toxicology studies as well as for analysis of clinical samples during human trials. Each time bioanalytical methods are transferred and validated, cost, time and the risk of variability and error are involved. The importance of having well developed methods, validating them per species and maintaining continuity from preclinical through clinical development studies with as little variability as possible, is of paramount importance for the success of any drug development program.

IITRI offers a range of bioanalytical services for the detection and quantitation of both small molecule and biologic drug candidates for preclinical and human clinical trial samples, and from difficult tissue matrices.

Core Services

  • Analytical method development and validation
  • Bioanalytical sample quantitation and analysis
  • Pharmacokinetics analysis
  • Dose formulation analysis
  • Toxicokinetic analysis and modeling
  • Clinical bioanalytical analysis of samples from human trials

In Vitro Assays

  • Enzyme-linked immunoassays (ELISA)
  • Immunogenicity testing
  • Cytokine expression
  • Assessment of biomarkers
  • qPCR, RT-PCR and full suite of PCR-based assays
  • EpiAirway 3D human airway tissue model for inhalation toxiclogy

Key Equipment

  • LC-MS/MS - AB SCIEX 5500
  • LC-QTRAP - AB SCIEX 4000
  • HPLC - Waters, Agilent
  • Robotic Sample Prep System - TomTec Quadra 3® SPE System
  • FTIR - Bruker
  • BD FACSCelesta™ Flow Cytometer

The IITRI Advantage

  • Highly experienced bioanalytical team with greater than 60% of the scientists holding advanced degrees
  • Demonstrated success in method development for even the most difficult drug candidates
  • All methods conform to regulatory guidelines as well as sponsor requirements
  • Expertise in GLP and GMP ELISA method development and validation
  • Smooth transfer of methods and data to/from central lab of choice