Vaccine Toxicology

IITRI has over 15 years of experience conducting GLP-compliant vaccine safety and toxicity studies on a variety of vaccine types including inactivated and live attenuated viral and bacterial preparations, plasmid DNA, nanoparticles, and viral vector immunotherapies, as well as adjuvanted vaccines.

We offer comprehensive GLP vaccine toxicology services including repeat-dose studies in rabbits, rodents and large animals (canine, ferret, and non-human primate/NHPs), biodistribution, and immunogenicity studies to meet FDA submission guidelines. We also offer GLP vaccine toxicology studies in ABSL-2 facilities for studies on live attenuated viral vaccines against infectious agents or as cancer vaccine immunotherapies.

In addition to our extensive experience with traditional vaccine platforms, IITRI has successfully collaborated with sponsors to advance the development of mRNA and lipid nanoparticle-based vaccines. These cutting-edge technologies offer rapid and flexible responses to emerging infectious diseases, enhancing immune responses and improving vaccine stability. Our team can conduct comprehensive GLP-compliant studies, including toxicity, immunogenicity, and biodistribution assessments, to support the safe and effective use of these innovative vaccine platforms. By integrating mRNA and lipid nanoparticle technologies into our vaccine toxicology services, IITRI continues to lead in the development of next-generation vaccines.

Vaccine Toxicity Studies

• Single and repeat dose
• Immunogenicity
• Clinical pathology and histopathology
• Immunological and virological in vitro assays: ELISA (including for C-reactive protein), qPCR, hemagglutination inhibition assay (HAI), and microneutralization assays (MN)
• Models have included rabbits, rats, mice, and ferrets

Vaccine Toxicology Experience