BSL-2 / BSL-3 Facilities
IITRI has an extensive history of providing high-quality preclinical services for the evaluation of vaccines and therapeutics for early efficacy challenge studies through IND-enabling, GLP-compliant immunogenicity, toxicology and safety studies. We work with community-acquired and highly pathogenic infectious diseases and select agents (for example influenza, Zika, VEE, Bacillus anthracis, and Yersinia pestis), requiring biosafety level 2 or 3 (BSL-2 or BSL-3) containment, including aerosol-delivered organisms.
We also provide GLP-compliant, BSL-2 toxicology services for preclinical evaluation of new therapeutics for the rapidly evolving fields of gene therapy, cell therapy, and cancer immunotherapy, from efficacy through IND-enabling studies.
High Containment Laboratory and Animal Facilities
IITRI has over 10,000 square feet of CDC-approved, Biosafety Level 2 and Biosafety Level 3+ laboratories (BSL-2 and BSL-3+), including BSL-3+ animal biosafety lab space (ABSL-3+). These labs are fully equipped with all required equipment, including biosafety cabinets and incubators for viral culture, microscopes, real-time PCR instruments and other equipment for in vitro analysis.
Our BSL-3 / ABSL-3+ facilities include bioaerosol generation and exposure systems for in vivo viral and bacterial inhalation challenge studies, or antiviral and antibiotic efficacy studies using aerosol delivery of pathogens.
Accreditations for Select Agent Studies
We are fully registered with the CDC and USDA for possession and use of select agents and toxins for development of medical countermeasures (MCM) against bioterrorism. We also have the distinction of being one of only two non-government laboratories that operate a Department of the Army approved Biological Surety Program, which requires enhanced record keeping, physical security, and a compliant Personnel Reliability Program.
Since 1975, IITRI animal facilities have been fully and continuously accredited by the Association for the AAALAC. Our animal care program is supervised by a full-time board certified, state licensed, and USDA accredited veterinarian. Institutional oversight, policy, training, and programmatic review are performed by our Institutional Animal Care and Use Committee (IACUC).
Highly Experienced Personnel
In vitro and in vivo studies conducted in our BSL-2 and BSL-3 facilities are directed by PhD virologists and bacteriologists, with extensive experience in high-containment laboratories for research and select agent studies. Our PhD, DABT study directors are experienced in gene therapy, vaccine development, and cancer therapeutics, and will conduct your BSL-2 safety and toxicology studies. Our technical staff is highly trained and experienced for conducting biosafety level 2 or 3 studies in infectious disease or GLP-compliant toxicology.
Full Suite of Supporting In Vitro Assays
Our in vitro assay support services are available to fully characterize viral or bacterial infection supporting animal studies or human clinical trials. We offer assay development, validation and performance verification for both non-GLP and GLP-compliant assays.
All Species Including NHPs
We offer an extensive collection of infectious disease animal models for efficacy studies and the capability for toxicology studies in the same species.
Learn more about our infectious disease efficacy animal models