---
name: IIT Research Institute
slug: iitri
site: cro
website_domain: iitri.org
summary: Midsize preclinical CRO specializing in GLP-compliant toxicology, IND-enabling safety studies, infectious disease vaccine development, and inhalation toxicology with onsite integrated laboratories and 60+ years of regulatory partnership experience. Headquartered in Chicago, United States.
tagline: GLP-compliant preclinical CRO with 60+ years of toxicology, infectious disease, and inhalation expertise.
founded_year: 
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: US
tier2_domain_verified: false
updated_at: 2026-06-22T07:00:55.733Z
services_count: 12
modalities_count: 1
indications_count: 3
locations_count: 1
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# IIT Research Institute

GLP-compliant preclinical CRO with 60+ years of toxicology, infectious disease, and inhalation expertise.

Listed on cro.directory.

## Summary

Midsize preclinical CRO specializing in GLP-compliant toxicology, IND-enabling safety studies, infectious disease vaccine development, and inhalation toxicology with onsite integrated laboratories and 60+ years of regulatory partnership experience. Headquartered in Chicago, United States.

## At a glance

- HQ country: US

## Services

- GLP Toxicology
- Carcinogenicity Studies
- In Vivo PK / PD Studies
- In Vivo Efficacy Models
- Preclinical In Vivo Studies
- Bioanalysis
- Immunogenicity Assays (ADA / NAb)
- Flow Cytometry Services
- Virology Services
- Microbiology Services
- Translational Research
- Pathology & Histology Services

## Modalities

- Vaccine

## Indications

- Infectious Disease
- Oncology
- Respiratory

## Locations

- Headquarters, Chicago, Illinois, United States

## Long description

## 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

_Profile last updated: 2026-06-22T07:00:55.733Z. Profile facts may include AI-assisted enrichment._

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