Monitor Process Parameters and CQAs trough Real Time Measurement (PAT)

Laura Montis, Agilent Technologies, Les Ulis, France (laura.montis@agilent.com)

High-performance liquid chromatography (HPLC) is a proven tool for the analysis of critical process parameters (CPP) and critical quality attributes (CQA) of biotherapeutics. Historically, HPLC has been performed off-line – a process that can take days or weeks to complete. By moving HPLC to the manufacturing floor as an on-line Process Analytical Technology (PAT) tool, relevant data can be accessed in a matter of minutes.

The utility of on-line HPLC to monitor and control antibody aggregation levels in bioprocessing will be demonstrated. The implementation of PAT enables continuous manufacturing and empowers industry progress towards Bioprocessing 4.0.

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Short Biography of Presenting Author

Laura began her carrier in the Liquid Chromatography over 15 years ago. After experiencing the pharmaceutical world in an analytical development lab, she went on to work with preparative chromatography and gained experience with Supercritical Fluid Chromatography prior to moving onto special HPLC applications, like 2DLC and On-line LC.

Throughout her career, Laura has held several positions, including application chemist, trainer, sales specialist, and marketing business development. She is currently responsible for liquid phase chromatography systems within the International Distributor Organization in EMEA of Agilent Technologies.

Laura studied analytical chemistry and holds a master’s degree from University of Lyon in France.