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Ex situ online monitoring: application, challenges and opportunities for biopharmaceuticals processes

Paul Kroll, Patrick Sagmeister, Wieland Reichelt, Lukas Neutsch, Tobias Klein & Christoph Herwig*

Monitoring of bioprocesses, especially biopharmaceutical production processes, is of utmost importance to ensure constant product quality and availability. Economical bioprocess development depends on time-efficient process development, aiming for in-depth understanding of the bioprocess and its critical parameters. Online monitoring of bioprocesses allows the assessment and processing of critical process data in real time. This is a prerequisite to permit real-time process management. Various devices for automated sampling and analysis, as well as data analysis and processing, have emerged over the last decade. In this review, we will cover the most important developments and novelties in the field of bioprocess monitoring from a methodological point of view. We focus on consolidation and processing of big amounts of data generated during a bioprocess and discuss how the proper interaction of hardware and software will improve bioprocess monitoring and control in the future.