The CDC estimates that HPV causes over 27,000 cases of cancer each year in the United States. However, with the vaccine costing over $200 per dose, prevention may not be financially feasible for some at-risk populations. One method to reduce cost is to explore more efficient vaccine manufacturing practices. The classic vaccine purification methods utilize chromatography and can account for over 35% of the operating costs of vaccine production due to the need for high volumes of elution buffer, expensive resins, and recoveries as low as 30%. Additionally, the batch style of manufacturing leads to staggered bursts of product availability and slower reaction time to spikes in demand. Our lab has developed an alternative purification process using aqueous two-phase systems (ATPS) in both batch and continuous (cATPS) configurations capable of achieving high purity in a two-step process with yields as high as 80%. We compared a two-step cATPS to a two-step column chromatography system. An incremental economic analysis shows that cATPS can reduce downstream operating expenditures by 50%, while greatly reducing consumables and related waste. Furthermore, with an average capital expense reduction of 96%, cATPS would greatly reduce the cost for expansion. By reducing the operating costs at the downstream processing stage, increasing product yields, and operating continuously, cATPS has the potential to reduce consumer costs and improve the availability of vaccines

Incremental economic analysis of continuous aqueous two-phase purification of vaccines

ACS Fall 2021

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