Tag Archives: biological processes

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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