<br/>Rapid commercialization of vaccines plays a key role in ensuring patient access. As market demand grows, process development and commercialization groups are tasked with transferring high-quality, reliable, and productive bioprocesses on compressed timelines. A case study describing the tech transfer of the purification process for a multi-valent vaccine is presented. This endeavor required many shakedown batches to prepare for a process performance qualification (PPQ) campaign. In parallel with late-stage process development, a brand-new facility was also being built from the ground up. Several issues needed to be solved to commission the facility while still learning about the set of manufacturing processes to be commercialized there. Challenges were encountered around balancing platform capabilities with the unique needs of each drug substance component, as well as around single-use assembly limitations and unexpected scale-up issues. Some mitigating actions included deep dives into equipment design, parallel bench-scale studies, and at-scale water runs. Thanks to collaboration across many different functions, several solutions were implemented towards the goal of qualifying a highly complex set of purification processes.

Accelerated tech transfer of a vaccine: Building the site while building the process

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.