Services for Researchers

Malaria Vaccine Production and Support Services

About

What services does this resource provide?

• 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).

Where are services provided?

Access

• What are the eligibility criteria?

• What assurances are provided to users?

• What is the application process?

• How are requests prioritized and/or approved?

• What requirements must users fulfill?

Related Resources and Information

Related Services

• Malaria Research and Reference Reagent Resource Center (MR4) (non-Government link)

• Vaccine and Treatment Evaluation Units (VTEUs)