In the pursuit of a continuous biopharmaceutical drug substance manufacturing paradigm it is important to not only consider the physical design of equipment but to also consider the supporting data and informatics infrastructure.  Indeed, the data collected from manufacturing operations must be complete, available and fully contextualized in order to link processing conditions to corresponding output material quality.  Such an informatics system will greatly facilitate process optimization and accelerate the goal of producing material manufactured via continuous processing that is of comparable quality to that obtained from traditional batch processing.    <br/>This presentation will focus on the design considerations for a robust data and informatics infrastructure to maximize data extraction and value from GlaxoSmithKline’s (GSK) Integrated Drug Substance Manufacturing (IDSM) system.  This comprehensive environment was optimized to facilitate both real time and secondary uses of data generated from a manufacturing system comprising 21 programmable logic controllers, 1000+ process sensors, eight spectrometers, nine automated at-line sampling points, and tens of thousands of configuration parameters.<br/>A topology was devised to direct the flow of data from various sources on the manufacturing system to primary repositories, secondary repositories and real time visualizations.  Major systems to achieve the data flow were surveyed, down selected, tested and ultimately selected for the informatics architecture.  The finalized structure makes use of software packages that meet the specific needs of continuous biopharmaceutical manufacturing and have demonstrated value and reliability in the pharmaceutical industry.  Collectively, these tools facilitate the holistic capture and analysis of real time and historical process, spectral, online, at-line and model-calculated data types.<br/>

Holistic data and informatics infrastructure for continuous biopharmaceutical 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.