(820f) Process Cost Modeling to Aid Decisions in Early Vaccine Development

Fundamental decisions made early in vaccine process development, such as expression system selection, can have profound impacts on the eventual manufacturing cost of the vaccine.  It is therefore desirable to consider manufacturing cost when making these early decisions; however, most manufacturing logistics are unknown early in development and it is difficult to gauge the impact of process variables on manufacturing cost.  In three case studies, process and cost modeling software was applied in order to provide input to decision early in vaccine development.  In the first case study, cost modeling was used to determine the minimum fermentation titer required to achieve an acceptable manufacturing cost for a single component vaccine.  This titer was then used as a criteria to screen fermentation expression systems.  In the second case study, cost modeling was used to compare expression systems for a multi-component vaccine.  This comparison demonstrated the importance of a platform expression system for a multi-component vaccine.  In a third case study, the cost impact of an affinity resin used in early stage development was evaluated to determine whether transition to more commercially available chromatography media would significantly impact product cost.