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

If you are interested in learning more about the use of Process Analytical Technology (PAT) and Quality by Design in Bioprocess Monitoring, you can view the on-demand webinar Tracking Inline Cell Count and Dimension to Ensure Targeted Cell Culture Productivity which was recently presented by Brian O’Sullivan.