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Analytical tools for monitoring changes in physical and chemical properties of chromatography resin upon reuse

Pathak, M; Lintern, K; Johnson, TF; Nair, AM; Mukherji, S; Bracewell, DG; Rathore, AS; (2019) Analytical tools for monitoring changes in physical and chemical properties of chromatography resin upon reuse. Electrophoresis , 40 (23-24) pp. 3074-3083. 10.1002/elps.201900089. Green open access

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Abstract

Protein A resins are often reused for multiple cycles to improve process economy during mAb purification. Significant reduction in binding capacity and product recovery are typically observed due to the presence of unwanted materials (foulants) deposited on the resin upon reuse. In this paper, we have used a wide spectrum of qualitative and quantitative analytical tools (particle size analysis, HPLC, fluorescence, SEM, MS, and FTIR) to compare the strengths and shortcomings of different analytical tools in terms of their capability to detect the fouling of the resin and relate it to chromatographic cycle performance. While each tool offers an insight into this complex phenomena, fluorescence is the only one that can be used for real‐time monitoring of resin fouling. A correlation could be established between fluorescence intensity and the process performance attributes (like yield or binding capacity) impacted upon resin reuse. This demonstration of the application of fluorescence for real‐time monitoring correlated empirically with process performance attributes and the results support its use as a PAT tool as part of a process control strategy. While the focus of this paper is on fouling of protein A chromatography resin, the approach and strategy are pertinent to other modes of chromatography as well.

Type: Article
Title: Analytical tools for monitoring changes in physical and chemical properties of chromatography resin upon reuse
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/elps.201900089
Publisher version: https://doi.org/10.1002/elps.201900089
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Column reuse, Fluorescence, Microscopy, PAT, Protein A chromatography
UCL classification: UCL
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Biochemical Engineering
URI: https://discovery.ucl.ac.uk/id/eprint/10084908
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