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Analytical tools for monitoring changes in physical and chemical properties of chromatography resin upon reuse
Author(s) -
Pathak Mili,
Lintern Katherine,
Johnson Thomas F.,
Nair Aswathy M.,
Mukherji Soumyo,
Bracewell Daniel G.,
Rathore Anurag S.
Publication year - 2019
Publication title -
electrophoresis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.666
H-Index - 158
eISSN - 1522-2683
pISSN - 0173-0835
DOI - 10.1002/elps.201900089
Subject(s) - reuse , fouling , process (computing) , process engineering , chromatography , fluorescence , high performance liquid chromatography , particle size , yield (engineering) , chemistry , computer science , materials science , waste management , engineering , membrane , composite material , biochemistry , physics , quantum mechanics , operating system
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.