Vaccine production and purification relies on the complex interplay between multiple unit operations and is not standardized: production strategies vary from vaccine to vaccine. The adoption of new technologies and advances in manufacturing capabilities can help foster accelerated vaccine discovery, development and deployment. Implementation of multifunctional single-use technology during vaccine purification provides an avenue to simultaneously reduce process complexity and compress the production process. When 3M™ Emphaze™ AEX Hybrid Purifier, a single-use anion exchange chromatography product, is incorporated in the purification scheme of recombinant protein-based vaccines it provides the potential to simplify the production process.<br/><br/>In this investigation, the production of a vaccine target was considered where primary clarification is currently accomplished using two-stage depth filtration. This strategy serves to remove large debris, however, soluble impurities such as Host Cell Proteins (HCPs) are not effectively cleared. As a result, HCP removal is accomplished downstream in the incumbent process using a series of chromatographic separations., Emphaze AEX Hybrid Purifier provided a higher reduction of soluble impurities compared to clarification using depth filtration alone. The appreciable reduction of the challenging HCP with Emphaze AEX Hybrid Purifier warranted exploration of potential downstream modifications, which can facilitate process compression and simplification. In addition, Emphaze AEX Hybrid Purifier is amenable to process condition manipulation which can improve product recovery.

Harvest chromatographic clarification enables simplification and compression in vaccine production

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.