Resources for Researchers
Malaria Vaccine Production and Support Services
About
What services does this resource provide?
The Malaria Vaccine Production and Support Services program provides preclinical and nonclinical services in support of malaria vaccine development, including:
- Development, characterization, and production of limited quantities of clinical grade material for lead candidates for malaria vaccines
- Development of processes to identify optimal production and purification strategies for clinical-grade immunogens
- Development of assays and reagents for product evaluation
- Formulation and production of pilot lots of clinical trial material
- Regulatory support for compiling documentation necessary for submission of an Investigational New Drug (IND) application and/or Master Files to the Food and Drug Administration (FDA).
As appropriate, studies may be conducted in compliance with GLP (Good Laboratory Practice) or GMP (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.
Where are services provided?
Services are provided by Science Applications International Corporation (SAIC) and subcontractors.
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