In recent years the biopharmaceutical industry has been exploring the utilization of continuous drug substance manufacturing to reduce facility footprint, labor requirements, and operating costs while maintaining target product output. The vision within GlaxoSmithKline (GSK) for a semi-continuous manufacturing platform is to maximize equipment utilization and reduce the capital investment required for future facilities, resulting in a flexible and small manufacturing platform that can support an expanding portfolio of assets with varying BDS manufacturing demands. To explore the technical feasibility of this manufacturing paradigm, a laboratory scale development facility has been designed and built to serve as a ‘sandbox’ for technology development. Within the laboratory, technology assessments, process development, and process de-risking can occur such that technology transfer and future manufacturing operations risks can be mitigated.<br/>This presentation will focus on the integrated approach GSK has taken focusing on three main aspects; equipment design, analytical strategy, and data management. First, the process flow, facility layout, automation control strategy, and key philosophies that drove the design of the system will be discussed. Furthermore, the combination of inline, online, and at-line analytical methods implemented to monitor critical quality attributes throughout the process will be outlined. Finally, the framework for the data management which allows for automated real time process monitoring, historization, data aggregation, and post-campaign visualization will be discussed. A facility designed with these capabilities can enable automated process operation, improve process monitoring, and drastically reduce documentation burdens. Together, an integrated semi-continuous platform designed with these capabilities promises to reduce labor costs and improve process control, in addition to the benefits that can be realized from continuous unit operations alone.

Integrated approach to semi-continuous drug substance manufacturing

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.