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Product Development and Manufacturing

The Challenge: Once researchers have identified a vaccine design that they believe is promising, a critical phase of vaccine research is developing a manufacturing process that yields consistent batches for clinical trials and is practical and affordable for eventual large-scale production. Manufacturing issues are particularly challenging for HIV vaccinesand may require different technologies depending on the nature of the vaccines. While a number of HIV vaccine candidates have been successfully manufactured in small batches for trials, the production processes are complex and cumbersome, and would be impractical for use on a large scale.

Recommendations: The Enterprise scientific plan calls for creating a network of vaccine manufacturing experts to engineer improved HIV vaccine production processes; these experts would be closely linked to vaccine discovery consortia and clinical trial sites. Such an effort will be particularly important as more HIV vaccine candidates are discovered and advance through clinical trials. Private industry involvement in such a network is critical, because most vaccine manufacturing expertise resides in the private sector.

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