(612a) The iSKID Platform: At the Crossroads of Technical Development and Manufacturing Readiness

Integrated and continuous bioprocessing (ICB) has been a trendy topic in the biotechnology community for over a decade. Numerous presentations and publications have disclosed conceptual process designs, introduced new/enabling technologies, and advocated the benefits of ICB over currently accepted batch strategies. Some of these efforts have progressed to full, lab scale demonstrations producing data showing appropriate product quality and increased overall productivity further justifying the excitement and focus on ICB. Despite these numerous proof-of-concept ICB examples, relatively few have reported on advancing to implementation. Reasons for this disconnect might include capital limitations, implementation strategy, disruption to current paradigms, or perceived risk.

This talk will describe Pfizer’s journey with the iSKID, an ICB platform that is currently being implemented for GMP manufacturing. Process design choices that helped enable implementation will be presented along with challenges encountered during the first at scale run. A high-level project plan for the first clinical molecule will be shown along with project mitigation strategies for implementation of this new technology. Product quality and process performance results from the at scale engineering run will be shown.

This talk will also look beyond the initial implementation of the iSKID to late-stage process development. Potential process control strategies that leverage multivariant models of the time dependent data series will be proposed. Finally, the value of the iSKID and ICB processes in general will be considered in the context of Pfizer’s diverse portfolio and broader manufacturing network.