The biopharmaceutical industry agrees that process analytical technologies (PATs) and automation will improve process consistency, enhance biologic quality, reduce production costs, and accelerate workflows. However, technologies for on- and in-line bioprocess monitoring generally remain in process development laboratories rather than being used on the manufacturing floor. Some difficulties stem from limitations with current sensing methods and technologies. Other problems relate to implementation and integration of existing information-technology (IT) solutions. And still other concerns arise when company leaders need to make a business case for investing in PAT infrastructure.

This eBook assesses the state of bioprocess monitoring. First, summaries of presentations from the 2022 BioProcess International Conference and Exhibition in Boston, MA, demonstrate how biopharmaceutical manufacturers are applying advanced instruments for on- and in-line analysis of increasingly complex bioprocess parameters. Among those technologies are solutions for rapid liquid chromatography–mass spectrometry (LC-MS) and Raman spectroscopy workflows. Next, the eBook provides impressions from CASSS’s January 2023 Well-Characterized Biological Products (WCBP) symposium in Washington, DC, specifically from a lively roundtable discussion focused on PAT, real-time release testing (RTRT), and modular manufacturing formats. Together, the summaries highlight applications in which biopharmaceutical companies have succeeded in introducing in-line monitoring systems. The eBook chapters also identify areas in need of further investigation, especially concerning use of automation to facilitate sampling and reintegration of in-process material. Read the eBook to learn about those topics and about needs for data collection, curation, and analysis.

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