Tag Archives: Brian O’sullivan

Why Use Process Analytical Technology (PAT)/Quality by Design (QbD) for Bioprocess Monitoring?

PAT and QbD in Bioprocess Monitoring

Use of PAT/QbD in BioProcess Monitoring

During a recent online seminar, Brian O’Sullivan discussed why Process Analytical Technology (PAT) and Quality by Design (QbD) are used for Bioprocess Monitoring.  Brian’s presentation included the following points:

  • When you think of biological processes, they are complex manufacturing processes with high process variability
  • Development of robust and reliable bioprocesses can be difficult
  • Increased risk of contamination due to sampling for offline measurement
  • Process losses can be high
  • Process Analytical Technology (PAT) provides a means of improved process understanding, optimization, and control
  • Return on Investment in Process Analytical Technology (PAT) comes from both R&D and manufacturing.  Typically, this is achieved by getting more robust processes to market quicker which ultimately minimizes the process risks from batch to batch and also improves process optimization
  • Process Analytical Technology (PAT) is critical in the transfer of knowledge from lab to manufacturing
  • Reduced sampling time and online method minimize contamination risks
  • Quality by Design (QbD) approach identifies and minimizes manufacturing risk through identification of Critical Quality Attributes (CQAs), what causes variability in CQAs, and control of CQAs
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World Congress on Particle Technology 6: FBRM and PVM real-time particle system characterization at WCPT6 in Nuremburg, Germany (26-29 April, 2010)

POWTECH-WCPT6-Nuremburg-METTLER-TOLEDO-FBRM-C35The particle size distribution is a critical parameter in process efficiency and product quality in many pharmaceutical, chemical and industrial processes. The real-time measurement of particle count, dimension and shape of particles as they actually exist in process provides critical process information that speeds up process understanding and enables a better means of real-time measurement and control.

At next week’s World Congress on Particle Technology in Nuremburg, two of my colleagues will be presenting papers covering research and case studies covering a variety of applications of real-time measurement of particle systems using on-line particle characterization tools.

The titles of the four papers that will be presented are listed below :

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Using Process Analytical Technology (PAT) to Ensure Targeted Cell Culture Productivity

Cell-Culture-Fermentation-Brian-OSullivan-METTLER-TOLEDO

Tracking Inline Cell Count and Dimension

Brian O’Sullivan will present Tracking Inline Cell Count and Dimension to Ensure Targeted Cell Culture Productivity on May 26.    During this free online seminar, case studies where Process Analytical Technology (PAT) was successfully applied to fermentation processes – including filamentous organisms, plant cells, mammalian cells, and E. Coli – will be reviewed.

Specific application examples that Brian will discuss are protein crystallization optimization, scale-up from shaker flasks to pilot scale, cell debris & cell debris flocculation, cell count & cell density monitoring in real time with no need for sampling, and cell culture productivity.

Visit the Tracking Inline Cell Count and Dimension to Ensure Targeted Cell Culture Productivity online seminar page for more information.