Process Analytical Technology (PAT) for Biotech - METTLER TOLEDO
White Paper

Process Analytical Technology (PAT) for Biotech

White Paper

Process Analytical Technology (PAT) in Fermentation & Bioprocessing

Learn How To Optimize Fermentation and BioProcessing.

This white paper reviews the use of Process Analytical Technology (PAT) in fermentation and bioprocessing, from monitoring biomass and culture conditions upstream, to downstream processes such as protein precipitation and flocculation of debris. Some highlights of the paper:

  • Process Analytical Technology (PAT) tools provide the opportunity for bioprocess optimization that is unachievable by traditional methods of offline sampling and analysis
  • Real-time monitoring of dynamic processes provides information that can be used for more effective screening and optimization of robust, scalable processes
  • Advanced PAT instrumentation, with applications from the laboratory to production scale, can be used to ensure that bioprocesses are performing as designed in the laboratory - providing confirmation of batch to batch reproducibility and allowing detection of process endpoints to maximize batch yield and productivity

This white paper also touches on in situ monitoring the biosynthetic processes of peptide synthesis and biocatalysis.

Within the pharmaceutical industry, process analytical measurement of critical process parameters is one of the key elements of the Process Analytical Technologies (PAT) framework and Quality by Design (QbD) initiative of the US FDA and other global regulatory agencies. In situ measurement of critical process parameters enables more accurate determination of process kinetics and dynamics to create more detailed understanding, more accurate models, and the capability of real-time control. Advanced Process Analytical Technologies can also be applied to greater understanding and optimization of fermentation and bioprocesses.