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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.

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Last Updated November 27, 2012