IITRI

Preclinical development services taking inhaled drug candidates from efficacy testing in COVID-19 animal models to full IND-enabling program support.

Comprehensive preclinical inhalation toxicity testing programs customized to your needs, covering acute, subchronic and chronic studies, PK and biodistribution, DART, and carcinogenicity studies.

Extensive collection of infectious disease animal models including influenza ferret models, NHP models for monkeypox or plague, and hamster/mouse models for SARS-CoV-2 available for efficacy testing.

Expert assistance in planning and executing gene therapy preclinical studies and programs for IND submissions, including GLP-compliant toxicology, biodistribution studies, and bioanalytical methods.

Standard battery of in vitro and in vivo genetic toxicology tests complying with ICH and OECD guidelines to support US EPA and FDA regulatory submissions for pharmaceuticals, chemicals, agrochemicals, and consumer products.

GLP toxicology studies combining expert toxicology, molecular biology, and virology capabilities in mouse tumor models, rodents, nonrodents, or NHPs.

Comprehensive GLP-compliant vaccine safety and toxicity studies including repeat-dose studies, biodistribution, and immunogenicity assessments for various vaccine types.

Preclinical carcinogenicity testing services including 2-year rodent bioassays and 6-month bioassays in genetically engineered mice.

Preclinical drug discovery and candidate selection services including efficacy studies, in vitro assays, animal models for cancer and infectious diseases, pharmacokinetic analysis, and non-GLP exploratory toxicology testing.

Contract research services for the development of new vaccines, medical countermeasures, antitoxins, and therapeutics against emerging infectious diseases and biothreats.

Comprehensive bioanalytical services for small and large molecule therapeutics, including method development, validation, and analytical method transfer fully compliant with FDA and ICH guidelines.

Comprehensive preclinical inhalation toxicology programs utilizing pulmonary drug delivery to support GLP-compliant IND submissions and risk assessments.

Comprehensive pharmacokinetic study services including quick turnaround PK screening for lead optimization, formulation evaluation, and full PK programs encompassing in-life study, bioanalysis, and PK modeling.

Preclinical service program for drug and vaccine evaluation under the FDA Animal Rule pathway, utilizing animal models in BSL-2 and BSL-3 containment facilities.

Comprehensive preclinical testing services for medical devices, including GLP-compliant toxicology, inhalation toxicology, microbiological testing, genotoxicity, bioburden analysis, and integrated support for drug-device combinations.

In-house analytical services providing method development, validation, dose formulation analysis, and clinical sample analysis for preclinical studies.

Bacterial reverse gene mutation assay utilizing E. coli and Salmonella strains.

Evaluation of chromosomal abnormalities using CHO or HPBL cells in vitro.

Evaluation of cell viability due to cytotoxicity using BALB/c-3T3 mouse fibroblasts.

Pre-clinical and clinical bioanalysis of APIs in complex biological matrices using LC-MS/MS and GC-MS platforms, supporting drug candidates from discovery to Phase IV clinical trials.

Preclinical histology and histopathology support services providing high quality data, on-site necropsy teams, and GLP compliant histopathological evaluations.

Qualified or GLP-compliant biodistribution analyses in tissues and fluids for vector or transgene quantitation.

Assays for the additional characterization of immunotoxicology mechanisms in accordance with ICH/EMA/FDA Guidance S8.

Immunoprofiling services to support efficacy proof of concept studies in xenograft and syngenic mouse tumor models.

Immunological laboratory services providing assay design for custom TK/PK drug concentration analysis, immunogenicity testing, and cell-mediated response assays.

Grant and subcontract support for startups, biotechnology companies, and academic researchers seeking funding for efficacy studies, safety, and IND-enabling toxicology.

Exploratory toxicology studies conducted in drug discovery to provide clues to a drug candidate's potential toxicity prior to initiating preclinical toxicology programs.

Fully OECD and GLP compliant toxicology studies and safety assessments for e-cigarettes, electronic nicotine delivery systems (ENDS), vaping devices, and modified tobacco products.

Characterization of immune cell populations isolated from peripheral blood, lymphoid organs, or tissues in preclinical animal studies.

Assays for the detection of an immune response against therapeutics or vaccines as part of an in-life study or for in vitro screening.