IIT Research Institute

Overview

IIT Research Institute (IITRI) is a midsize preclinical contract research organization headquartered in Chicago, Illinois, with over 60 years of experience supporting government agencies, biotechnology companies, and pharmaceutical partners. The organization operates a single 100,000 square foot integrated facility housing all study functions, enabling seamless coordination and consistent quality.

Core Capabilities

Toxicology & Safety Testing

• GLP-compliant preclinical toxicology and drug safety evaluation since 1979
• Full range of in vivo toxicology testing including acute, subchronic, chronic, and repeated-dose studies
• Maximum-tolerated dose (MTD) and dose-range finding studies
• Reproductive toxicology including juvenile studies
• Carcinogenicity studies (2-year and 6-month transgenic mice)
• All relevant routes of administration and model species including non-human primates
• IND-enabling and NDA-enabling programs

Infectious Disease & Biodefense

• Vaccine development and medical countermeasures (MCMs) evaluation
• Immunogenicity, efficacy, potency, and safety assessment of vaccines, antitoxins, and therapeutics
• Experience with emerging infectious diseases (COVID-19, monkeypox, Zika, influenza, RSV, antibiotic-resistant bacteria)
• Biosafety Level 2 and 3+ facilities registered with CDC and USDA for select agents and toxins
• Bioaerosol generation and aerosol exposure systems for inhalation pathogen delivery and therapeutic efficacy studies

Inhalation Toxicology

• Comprehensive preclinical inhalation toxicology services for inhaled drug development
• Infectious aerosol challenge studies in BSL-2 and BSL-3 containment
• Occupational health and environmental risk assessments
• Electronic cigarette and flavor studies
• Pulmonary drug delivery programs supporting GLP-compliant IND submissions

Immunological Support

• Custom TK/PK drug concentration analysis
• Anti-drug antibody (ADA) immunogenicity testing
• Flow cytometric immunophenotyping
• Antigen-specific cellular response assays (ELISpot, intracellular cytokine staining)
• Cytokine production analysis (ELISA, ECL, Luminex, cytometric bead array)
• Neutralizing antibody (NAb) analysis
• GLP-compliant method development, qualification, and validation
• FDA-compliant sample quantitation from preclinical and clinical studies

Drug Discovery & Development

• Preclinical efficacy studies of drug candidates
• In vitro assays and animal models for cancer and infectious disease
• Pharmacokinetic analysis and exploratory toxicology for risk assessment
• Integrated preclinical testing strategy development
• Customized study design tailored to drug candidate characteristics and timelines

Integrated Laboratory Services

• Onsite analytical, bioanalytical, microbiology, molecular biology, immunology, histopathology, and clinical pathology laboratories
• Clinical trial sample analysis
• Fully accredited vivarium for rodent and non-rodent species
• Inhalation exposure suites for small and large animals

Regulatory & Quality

• GLP-compliant operations since 1979
• Strong relationships with FDA and other regulatory agencies
• Long-standing partnership with the National Cancer Institute
• QA/QC unit with relevant accreditations
• FDA guideline compliance for method validation and sample quantitation