Implementation of machine learning tool for continued process verification of process chromatography unit operation

•A strategy for achieving CPV for cation exchange chromatography is presented.•SPC charts generated based on real-time measurement of the various CPPs and CQAs.•Python-based program to read these SPC charts and respond to any deviation.•Combination of analyzers, soft sensors, and advanced data analy...

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Veröffentlicht in:	Journal of Chromatography A Jg. 1742; S. 465642
Hauptverfasser:	Anupa, Anupa, Jesubalan, Naveen G., Trivedi, Rishika, Nitika, Nitika, Buddhiraju, Venkata Sudheendra, Runkana, Venkataramana, Rathore, Anurag S
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Netherlands Elsevier B.V 08.02.2025
Schlagworte:	artificial intelligence Artificial intelligence (AI) biopharmaceutical industry biopharmaceuticals Cation exchange chromatography Chromatography, Ion Exchange - methods Continued process verification (CPV) data analysis Deep neural network (DNN) Machine Learning Machine learning (ML) Monoclonal antibodies near-infrared spectroscopy process control process design Raman spectroscopy Spectrum Analysis, Raman Monoclonal antibodies Machine learning (ML) Continued process verification (CPV) Artificial intelligence (AI) Cation exchange chromatography Deep neural network (DNN)
ISSN:	0021-9673, 1873-3778, 1873-3778
Online-Zugang:	Volltext
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