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Cross-scale quality assessment of a mechanistic cation exchange chromatography model

Saleh, David; Wang, Gang; Mueller, Benedict; Rischawy, Federico; Kluters, Simon; Studts, Joey; Hubbuch, Jürgen

Cation exchange chromatography (CEX) is an essential part of most monoclonal antibody (mAb) purification platforms. Process characterization and root cause investigation of chromatographic unit operations are performed using scale down models (SDM). SDM chromatography columns typically have the identical bed height as the respective manufacturing‐scale, but a significantly reduced inner diameter. While SDMs enable process development demanding less material and time, their comparability to manufacturing‐scale can be affected by variability in feed composition, mobile phase and resin properties, or dispersion effects depending on the chromatography system at hand. Mechanistic models can help to close gaps between scales and reduce experimental efforts compared to experimental SDM applications. In this study, a multicomponent steric mass‐action (SMA) adsorption model was applied to the scale‐up of a CEX polishing step. Based on chromatograms and elution pool data ranging from laboratory‐ to manufacturing‐scale, the proposed modeling workflow enabled early identification of differences between scales, for example, system dispersion effects or ionic capacity variability. ... mehr

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Verlagsausgabe §
DOI: 10.5445/IR/1000125352
Veröffentlicht am 28.10.2020
Cover der Publikation
Zugehörige Institution(en) am KIT Institut für Bio- und Lebensmitteltechnik (BLT)
Publikationstyp Zeitschriftenaufsatz
Publikationsjahr 2020
Sprache Englisch
Identifikator ISSN: 1520-6033, 8756-7938
KITopen-ID: 1000125352
Erschienen in Biotechnology progress
Vorab online veröffentlicht am 14.09.2020
Nachgewiesen in Scopus
Web of Science
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