Bioanalytical
Services
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Bioanalytical
Bioanalytical (Bio-A) laboratory services are the cornerstone to the success of preclinical PK and toxicology studies, providing drug concentration analysis of dose samples, serum, fluids, and tissues. IITRI’s highly experienced team has proven success in bioanalytical method development of even the most difficult drug compounds for quantitation in complex tissues. Our GLP-compliant bioanalytical laboratory is onsite at our single Chicago, IL location for efficient and transport-free coordination of study teams and sample analysis.
We comply with FDA guidelines for bioanalytical method validation and quantitation of your small molecule or biologic in complex tissues and fluids, from preclinical studies like biodistribution to GLP-compliant IND enabling programs. We also support human clinical trial sample analysis for Phase I, II, and III trials.
| Preclinical Services |
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• Analytical method development and validation • Bioanalytical sample quantitation and analysis • Biodistribution and bioequivalence • Dose formulation analysis • Toxicokinetic analysis and modeling • Bioanalysis of samples from human clinical trials • Studies using radiolabeled drugs
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| In vitro Assays |
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• Enzyme-linked immunoassays (ELISA) • Immunogenicity testing • Cytokine expressionAssessment of biomarkers • qPCR, RT-qPCR and full suite of PCR-based assays • EpiAirway 3D human airway tissue model for inhalation toxiclogy |
| Key Equipment |
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• LC-MS/MS – AB SCIEX 6500 • LC-MS/MS – AB SCIEX 5500 • LC-QTRAP – AB SCIEX 4000 • HPLC – Waters, Agilent, Shimadzu • TomTec Quadra 3® Automated 96-well SPE System • FTIR – Bruker • Opentrons OT-2 Liquid Handling System • Spex SamplePrep Mini G Tissue Homogenizer • BD FACSCelesta™ Flow Cytometer, 14-parameter multi-color • Bio-Rad CFX384 Touch Real-Time qPCR Detection System |
The IITRI Advantage
- Highly experienced bioanalytical team with greater than 60% of the scientists holding advanced degrees
- Expertise in GLP ELISA method development and validation
- Smooth transfer of methods and data to/from central lab of choice
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