THE SMART SOLUTION FOR
PRECLINICAL DEVELOPMENT
VACCINE DEVELOPMENT SERVICES
With over 15 years of experience conducting preclinical vaccine development studies, Noble Life Sciences offers GLP and non-GLP in vivo and in vitro vaccine services including
Vaccine Development Examples
- 5 to 3,000 mouse immunogenicity tests
- 10 to 250 guinea pig immunogenicity tests
- 3 to 25 ferret influenza challenge studies
- 10 to 100 rabbit efficacy studies
- 70 mini-pig biodistribution studies
Protocol Development
- Adjuvant selection – standard options, others on request
- Immunogen formulation
- Dosing regimen determination
Immunogenicity Testing
- Immunization and boost
- Pre- and post-injection sample collection
- Potency determination
Challenge-Protection Studies
- Clinical observations – animal weight, body temperature, clinical symptoms
- In vitro determinations
Toxicology Studies
- Single-dose acute and repeat-dose studies
- Biodistribution studies
- Clinical observations; complete clinical chemistry and pathology package
Related Services
- Immunoassays including ELISA, flow cytometry, neutralizing antibody assays
- Viral titers in serum or other tissues
- Immunoassay development
- Vaccine stability testing at various temperatures with potency testing
- Custom polyclonal antibody production for potency testing
In Vivo Options
- Mice
- Rabbits
- Guinea Pigs
- Ferrets
- Others on request
Proven Expertise
We have experience with a variety of mammalian species used for vaccine and drug development. Our studies range from single digit to hundreds of animals.
Our scientists, with over 15 years of GLP experience, provide all aspects of the GLP process from design to regulatory support of your IND, IDE or PMA FDA submission.