Development Strategy

MVDB’s primary mission is the development and clinical testing of prototype malaria vaccines. Each candidate vaccine has to undergo a rigorous development process that requires the input of many highly skilled scientists with specific areas of expertise. These include creation of expression systems, fermentation optimization, scale-up of purification technology, cGMP production, formulation, quality control, preclinical testing, and clinical trials. Each step in the development process requires an awareness of regulatory constraints and a disciplined adherence to formal SOPs, protocols, and recordkeeping.

This product-oriented research is different from the investigator-initiated research conducted in most laboratories. The need for multiple, highly technical inputs makes it impractical to have a single person knowledgeable in all aspects of a specific product.

For these reasons, we have adopted an organizational structure used almost universally by biotechnology companies to conduct this development process. This model for producing malaria vaccines incorporates best practices from both the public and private sectors to rapidly advance vaccine products into Phase II clinical trials. Our organizational approach is coupled with creative management practices, allowing us to operate and fund the program within the framework of the federal government.

The development timeline for MVDB presents the current and planned activities over the next 5 years. It identifies critical elements necessary for the program to continue to succeed in its mission.

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