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2023 | March / April 2023

Advancing PAT Solutions for the Bioprocessing Industry

by cyb2025
M. Wetterhall
bioprocess
Critical Process Parameters (CPPs)
Critical Quality Attributes (CQAs)
Liquid Chromatography (LC)
Mass Spectrometry (MS)
PAT
Process Analytical Technologies (PAT)

MAGNUS WETTERHALL
Global Marketing Manager – Bioprocessing, Waters Corporation, Sweden

ABSTRACT

There is a strong drive to explore and implement new tools for process analytical technology (PAT) in biopharmaceutical drug development and manufacturing. Their implementation facilitates real time monitoring and control of critical quality attributes (CQAs) and critical process parameters (CPPs) throughout the discovery, development, and manufacturing of biologics. Having access to high performing and comprehensive analytics render in better process understanding, improved operational robustness and reduced risk of costly batch failures. Streamlined and easy-to-use instrumentation for liquid chromatography (LC) and mass spectrometry (MS) allow bioprocess engineers to take control of cell culturing and process developments with their own high-quality and high-confidence data without being an MS expert.

The interest in exploring new tools for process analytical technology (PAT) in biopharmaceutical drug development and manufacturing is strong throughout the industry. However, despite the concept being well accepted and supported for almost two decades, the adoption of PAT in manufacturing settings is slower than first anticipated.

ABOUT THE AUTHOR

Magnus Wetterhall has more than 25 years’ experience in upstream & downstream bioprocessing, advanced mass spectrometry, biomarker discovery, protein characterization, working at start-ups, large biotech companies as well as academics. Magnus earned his M.Sc. and Ph.D. degree in analytical chemistry at Uppsala University, Sweden. He has published over 40 scientific papers and 50 posters in the areas of mass spectrometry, biomolecule characterization and bioseparations, and has been an invited presenter at national and international conferences on these topics. He is currently the Global Marketing Manager at Waters Corporation – Bioprocessing, where he is dedicated to deliver analytical solutions to advance upstream and downstream bioprocess.

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