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• W2904288380 abstract "Process analytical technology is gaining interest in the biopharmaceutical industry as a means to enable consistency in processing and thereby in product quality via process control. Protein refolding is known to be significantly impacted by critical process parameters and feed material attributes including composition and pH of the solubilisation and refolding buffers. Hence, to achieve robust process control and product quality, these attributes and parameters need to be monitored. This paper presents an approach towards statistical process control and monitoring of protein refolding, from buffer preparation to refold quenching, during manufacturing of therapeutic proteins from Escherichia coli based systems. The proposed approach utilises measurements of online redox potential, temperature, and pH for development of a statistical model. The model has then been integrated with LabView to permit real-time monitoring of the refolding process. The proposed system has been demonstrated to successfully identify process deviations and thereby enable process control for manufacturing product of consistent quality." @default.
• W2904288380 created "2018-12-22" @default.
• W2904288380 creator A5005684143 @default.
• W2904288380 creator A5072246495 @default.
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• W2904288380 date "2019-01-18" @default.
• W2904288380 modified "2023-10-17" @default.
• W2904288380 title "Process analytical technology implementation for protein refolding: GCSF as a case study" @default.
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• W2904288380 doi "https://doi.org/10.1002/bit.26900" @default.
• W2904288380 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/30552665" @default.
• W2904288380 hasPublicationYear "2019" @default.
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