As a leading provider of infectious disease contract research services, our Molecular and Microbiology Division offers a wide range of studies for the development of new vaccines or medical countermeasures (MCMs) including the evaluating the immunogenicity, efficacy, potency, and safety of vaccines, antitoxins and therapeutics. IITRI has extensive experience in the development of vaccines against emerging infectious diseases such as COVID-19, monkeypox, Zika virus, influenza, antibiotic resistant bacteria (i.e., superbugs) and fungi (Candida sp.) or respiratory syncytial virus (RSV), which continue to pose a threat to public health both in the US and abroad. We are also highly experienced in handling bacterial or viral infectious agents that are potential bioterrorism agents when aerosolized, such as Bacillus anthracis (anthrax) and Yersinia pestis (plague), in animal challenge studies.

Our laboratory and vivarium space includes Biosafety Level 2 and 3+ facilities and is registered with the CDC and USDA for use of select agents and toxins. Our BSL-3 lab houses our bioaerosol generation and aerosol exposure system for inhalation delivery of pathogens or anti-infective treatments for viral or bacterial aerosol challenge studies and therapeutic efficacy studies for antibiotics or antivirals.

Immunological laboratory services are crucial for the success of preclinical and clinical trial studies. IITRI’s immunological support includes designing assays for custom TK/PK drug concentration analysis of dose samples, serum, fluids, and/or tissues. Support also includes immunogenicity testing via anti-drug antibodies (ADAs), flow cytometric immunophenotyping, antigen-specific cellular response (ELISpot or intracellular cytokine staining), cytokine production (ELISAs or multiplexing via ECL, Luminex, or cytometric bead array platforms), neutralizing antibody (NAb) analysis, etc.

IITRI’s highly experienced team has proven success in immunological method development, qualification, and validation of custom, commercial, or transferred methods for analysis of samples from toxicology, efficacy, infectious disease, and clinical studies. Our GLP-compliant laboratory is onsite at our Chicago, IL location for efficient and transport-free coordination of study teams and sample analysis, we also accept sample transfer from outside sources. We comply with FDA guidelines for method validation and quantitation of samples from preclinical and clinical trial studies.

The successful path from preclinical drug discovery to candidate selection is a complex, iterative process that requires an integrated, interdisciplinary approach. IITRI’s experienced team of toxicologists, immunologists, analytical chemists, cancer biologists, infectious disease scientists, and molecular biologists partner with sponsors to develop the appropriate preclnical testing strategy to evaluate and advance lead drug candidates towards the clinic.

We offer a range of preclinical research services including efficacy studies of drug candidates, with in vitro assays and animal models available for cancer and infectious diseases. We also work with sponsors to explore the exposure and toxicology of lead candidates utilizing pharmacokinetic analysis and non-GLP exploratory toxicology testing for risk assessment of moving forward into GLP toxicology and safety programs.

To advance new drug candidates into clinical trials, a high-quality preclinical development program that meets FDA regulatory guidelines and is managed by a team you trust is of paramount importance. IITRI’s experienced study directors work collaboratively with you to design a customized preclinical testing program that is tailored to the characteristics of your drug candidate and your timeline, and follows regulatory guidelines.

As a preclinical CRO, IITRI offers all functions of drug development studies at one location, including toxicology, pathology, and bioanalytical, for seamless management of your IND-enabling studies and programs.

ITRI offers comprehensive preclinical inhalation toxicology services for development of inhaled drugs, infectious aerosol challenge studies in BSL-2 and BSL-3 containment, occupational health and environmental risk assessments, and electronic cigarette or flavor studies. Our comprehensive preclinical inhalation toxicity testing programs utilizing pulmonary drug delivery are customized to support GLP-compliant IND submissions for pharmaceuticals and the intended inhalation delivery device. We also offer early preclinical and NDA-enabling inhalation toxicology services for complete end-to-end coverage of regulatory requirements. Our laboratories are well equipped with multi-port inhalation exposure systems to perform nose-only inhalation toxicity studies on mice, rats, rabbits, canines and non-human primates (NHPs). 

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.