Process Analytical Technology (PAT): Batch-to-batch reproducibility of fermentation processes by robust process operational design and control-Reference-Cited by-同舟云学术

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

Published:2007-10 Issue:2 Volume:132 Page:180-186
ISSN:0168-1656
Container-title:Journal of Biotechnology
language:en
Short-container-title:Journal of Biotechnology

Author:

Gnoth S.,Jenzsch M.,Simutis R.,Lübbert A.

Publisher

Elsevier BV

Subject

Applied Microbiology and Biotechnology,General Medicine,Biotechnology,Bioengineering

Reference25 articles.

1. Characterizing biological products and assessing comparability following manufacturing changes;Chirino;Nat. Biotechnol.,2004

2. PAT: taking process monitoring to next level;DePalma;Gen. Eng. News,2004

3. FDA, 2004. Guidance for Industry: PAT-A Framework for Innovative Pharmaceutical Manufacturing & Quality Assurance, http://www.fda.gov/cvm/guidance/published.html.

4. Neural Networks: A Comprehensive Foundation;Haykin,1999

5. ICH, 2005. Q9—Quality Risk Management, at Step 4 of the ICH Process, November 9th, 2005. Q8-Q10 available at www.ich.org.

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