Process Analytical Technology (PAT): Online Monitoring and Control of Upstream Titer, Product Quality and Amino Acid Content Using 2D-LC with SegFlow Interface

September 2, 2020
Agilent Technologies, Inc.

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Biopharmaceutical companies are transitioning from “quality-by-testing” philosophy to “quality-by-design” paradigms, and establishing QbD-based PAT tools to increase product and process understanding. Due to the deficit of analytical methods to support QbD-driven continuous bioprocessing, biopharmaceutical companies are actively developing PAT tools to comply with QbD regulations. Europe Broadcast: Wednesday, Sept. 30, 2020 at 9am EDT | 2pm BST | 3pm CEST US Broadcast: Wednesday, Sept. 30, 2020 at 2pm EDT | 1pm CDT | 11am PDT On demand available after final airing until Sept. 30, 2021.

Register free: http://www.chromatographyonline.com/lcgc_w/n-glycan

Event Overview:

This webcast highlights the application of Agilent 2D-LC with SegFlow automatic sampler for online monitoring and control of titer and critical product quality attributes (CQA) of monoclonal antibodies and fusion proteins. Other applications include, but are not limited to near-real-time amino acid quantitation and feedback control to maintain the homeostasis of cells in bioreactors. The integrated system is an enabling technology to fill the gap of current deficit in Process Analytical Technology (PAT) to support QbD driven continuous bioprocessing. Continuous bioprocessing, referred as “Next Generation Manufacturing” is intended to achieve:

  • Increased product quality
  • Improved batch-to-batch reproducibility
  • Miniaturization of manufacturing footprint
  • Enhanced process understanding and robustness
  • Increased efficiency and flexibility
  • Reduced capital expenses and operating cost

Key Learning Objectives:

Introduction of the role of PAT in continuous bioprocessing/next generation manufacturing

  • Sharing the challenges of PAT tool development for biopharmaceuticals
  • Overview of the importance of appropriate integration of PAT tools for real-time monitoring and control of processes
  • Significance of PAT implementation to reduce turn-around time and increase sample integrity

Speaker: Dr. Letha Chemmalil, Principal Scientist, Bristol-Myers Squibb

Time and Date: Europe Broadcast: Wednesday, Sept. 30, 2020 at 9am EDT | 2pm BST | 3pm CEST

US Broadcast: Wednesday, Sept. 30, 2020 at 2pm EDT | 1pm CDT | 11am PDT

On demand available after final airing until Sept. 30, 2021.

Sponsor: Agilent Technologies, Inc.

Register free: http://www.chromatographyonline.com/lcgc_w/segflow

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