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Process Analytical Technology (PAT): Batch-to-batch reproducibility of fermentation processes by robust process operational design and control ☆

Paper ID Volume ID Publish Year Pages File Format Full-Text
24946 43547 2007 7 PDF Available
Title
Process Analytical Technology (PAT): Batch-to-batch reproducibility of fermentation processes by robust process operational design and control ☆
Abstract

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.

Keywords
PAT; Robust process design; Feedback control
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Process Analytical Technology (PAT): Batch-to-batch reproducibility of fermentation processes by robust process operational design and control ☆
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Publisher
Database: Elsevier - ScienceDirect
Journal: Journal of Biotechnology - Volume 132, Issue 2, 31 October 2007, Pages 180–186
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us