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. In this webinar, we highlight an initial use case, demonstrating the utility of on-line HPLC to monitor and control antibody aggregation levels in bioprocessing. The implementation of PAT enables continuous manufacturing and empowers industry progress towards Bioprocessing 4.0.
In this webinar, you will learn:
- How Process Analytical Technology (PAT) tools can facilitate progress towards Biopharma 4.0 and real-time release
- How on-line HPLC can be implemented in a bioprocessing environment
- The application of on-line HPLC to monitor and control critical quality attributes in bioprocessing
Speakers
Stacy Shollenberger
Merck
Senior Marketing Manager, Process Analytical Technologies
Stacy Shollenberger holds an MS degree in Biochemistry from the University of Virginia and an MBA from Penn State University. She has more than 12 years of experience in analytical and bioanalytical product and method development. Currently, Stacy is a senior manager of process analytical technologies (PAT) at Merck and is responsible for defining the PAT strategy to move testing from traditional off-line quality control (QC) to QC on the bioprocessing floor.
Daniel Kutscher, Ph.D.
Agilent Technologies
Product Manager, Strategic Marketing
Dr. Daniel Kutscher is a biochemist and experienced life-science professional with global responsibilities as a product manager for analytical HPLC. Daniel received his Ph.D. in 2011 from Justus-Liebig-University in Giessen, Germany, under the supervision of Prof. Dr. Alfred Pingoud. After completing his Ph.D., he moved to New York City, USA, and worked until 2018 as an HPLC product specialist, supporting customers in various industries. Daniel currently works for Agilent Technologies as a product manager - strategic marketing with a strong focus on better connecting the analytical with the (bio-) process world.
Pharma and biopharma manufacturing
- Downstream Processing
Duration:1h
Language:English
Session 1:presented November 17, 2022
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