Process Analytical Technology (PAT) for Biotech: A Review of Recently Reported Applications in Fermentation and BioProcessing
Fermentation and bioprocessing play critical roles in the discovery and manufacture of new pharmaceuticals and specialty chemicals, and in the sustainable production of bulk fuels and commodity chemicals. Yet fermentation processes are often operated with a minimal level of monitoring and control, limiting the ability to optimize yields and production rates.
Fermentation processes involve living cells that can be extremely sensitive to slight changes in their environment. As a result, many bioprocesses exhibit a significant amount of natural batch-to-batch variability. Offline sampling and analysis of optical density (OD) and concentration of multiple analytes – via High Performance Liquid Chromatography (HPLC) and other methods – has helped understand and improve the operation of bioreactors, but there can be significant cost and time delay involved in withdrawing, preparing, and analyzing samples on an ongoing basis. In fed-batch fermentation, which often relies on the controlled concentration of a specific limiting nutrient, time-delays can result in significant deviations from optimal operation.
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.
A new white paper – Process Analytical Technology (PAT) for Biotech – reviews the optimization of fermentation and bioprocessing:
- Process Analytical Tools can 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 about the kinetics of fermentation and bioprocesses that can be used for more effective screening, characterization and optimization of robust, scalable processes
- Advanced Process Analytical Technology (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 enable maximization of batch yield and productivity
“The 20th century was shaped by spectacular breakthroughs in physics and chemistry, but the stars of the 21st century will be the biological sciences, and those deciphering the genetic code of life. “
Jeremy Rifkin, The Biotech Century: Genetic Commerce and the Dawn of a New Era
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