Preclinical Vaccine Development Services 2018-06-20T07:37:40+00:00

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.

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