IIT Research Institute
IITRI is a full-service GLP-compliant preclinical contract research organization with over 40 years of experience. It specializes in toxicology, safety studies, infectious disease vaccine and therapeutic development, immunogenicity, inhalation toxicology, and gene therapy preclinical studies. IITRI collaborates with sponsors to plan and execute studies, providing personalized attention and expert guidance to support regulatory submissions and clinical development.
Industries
Nr. of Employees
medium (51-250)
IIT Research Institute
Services
Preclinical toxicology and safety testing
GLP-compliant in vivo toxicology studies (acute to chronic, reproductive, carcinogenicity, MTD/DRF) and support for regulatory submissions.
Inhalation toxicology and aerosol challenge studies
Inhalation exposure testing using multi-port and nose-only systems, aerosol challenge studies in BSL-2/3 containment for inhaled drugs and infectious agents.
Bioanalytical services
Method development, qualification and GLP bioanalysis for quantitation of drugs and biologics in complex matrices to support PK, toxicology and clinical sample analysis.
Immunology and immunogenicity testing
Assay development and execution for ADA, cellular immune responses, cytokine profiling and neutralizing antibody measurement with method validation support.
Genetic toxicology testing
Complete battery of in vitro and in vivo genetic toxicology assays conducted per ICH and OECD guidelines with on-site dose analysis.
Gene and cell therapy preclinical studies
Tailored preclinical programs for viral and non-viral gene therapies including biodistribution, vector quantitation, immunogenicity and GLP toxicology support.
Preclinical toxicology and safety testing
GLP-compliant in vivo toxicology studies (acute to chronic, reproductive, carcinogenicity, MTD/DRF) and support for regulatory submissions.
Inhalation toxicology and aerosol challenge studies
Inhalation exposure testing using multi-port and nose-only systems, aerosol challenge studies in BSL-2/3 containment for inhaled drugs and infectious agents.
Bioanalytical services
Method development, qualification and GLP bioanalysis for quantitation of drugs and biologics in complex matrices to support PK, toxicology and clinical sample analysis.
Immunology and immunogenicity testing
Assay development and execution for ADA, cellular immune responses, cytokine profiling and neutralizing antibody measurement with method validation support.
Genetic toxicology testing
Complete battery of in vitro and in vivo genetic toxicology assays conducted per ICH and OECD guidelines with on-site dose analysis.
Gene and cell therapy preclinical studies
Tailored preclinical programs for viral and non-viral gene therapies including biodistribution, vector quantitation, immunogenicity and GLP toxicology support.
Expertise Areas
- Preclinical toxicology and safety assessment
- IND/NDA-enabling study programs
- Inhalation toxicology and aerosol exposure
- Biodefense and infectious disease models
Key Technologies
- qPCR / RT-qPCR
- ELISA
- ELISpot
- Flow cytometry