Process Analytical Technology (PAT): batch-to-batch reproducibility of fermentation processes by robust process operational design and control.
The Process Analytical Technology (PAT) initiative of the FDA is a reaction on the increasing discrepancy between current possibilities in process supervision and control of pharmaceutical production processes and its current application in industrial manufacturing processes. With rigid approval practices based on standard operational procedures, adaptations of production reactors towards the state of the art were more or less inhibited for long years. Now PAT paves the way for continuous process and product improvements through improved process supervision based on knowledge-based data analysis, "Quality-by-Design"-concepts, and, finally, through feedback control. Examples of up-to-date implementations of this concept are presented. They are taken from one key group of processes in recombinant pharmaceutical protein manufacturing, the cultivations of genetically modified Escherichia coli bacteria.
Gnoth
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S
Center for Bioprocess Engineering, Martin-Luther-University Halle-Wittenberg, Germany.
Jenzsch
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M
Simutis
R
R
Lübbert
A
A
D019149:Bioreactors; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards*; D004345:Drug Industry / Q000592:standards*; D005285:Fermentation; D007218:Industrial Microbiology / Q000592:standards*; D007700:Kinetics; D011786:Quality Control; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration