Bioanalytical

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

We work closely with you on bioanalytical method development for the detection of your small molecule or biologic in complex tissues and fluids. Validated methods are used for bioanalysis in preclinical studies from early non-GLP studies through GLP-compliant IND enabling programs. We also support human clinical trial sample analysis for Phase I and II trials.

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