Resources for Researchers
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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