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Leading research to understand, treat, and prevent infectious, immunologic, and allergic diseases
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Vaccine Development Services

What services are provided?

The Vaccine Development Services is intended for use in the investigation, control, prevention, and treatment of a wide range of infectious agents other than HIV. The Vaccine Development Services supports the following products: vaccines, vaccine components including adjuvants, vaccine delivery systems, other biologics, and BSL-2, BSL-3, and BSL-4 challenge material.

The suite of services provided by the Vaccine Development Services includes

  • Vaccine Testing Services
    • Assay Development for Non-Clinical and Clinical Samples
    • Non-Clinical Immunogenicity and Efficacy Studies
    • Clinical and Non-Clinical Sample Testing
    • Safety and Toxicity Testing
  • Vaccine Manufacturing Services
    • Feasibility, Gap Analysis, and Product Development Plan Support
    • Process Development
    • Product Release Assay Development including Potency Assays
    • Pilot and cGMP Manufacture
    • Audits
    • Regulatory Activities and Documentation

As appropriate, studies may be conducted in compliance with GLP (Good Laboratory Practice) and cGMP (Current Good Manufacturing Practice).

Note: Resources are limited and intended to fill critical gaps and are not to be the sole source of product development. Preliminary data to support program participation are required.



Last Updated November 27, 2012