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Modeling the impact of amino acid substitution in a monoclonal antibody on cation exchange chromatography

Saleh, D. 1; Hess, R. 1; Ahlers-Hesse, M.; Beckert, N.; Schönberger, M.; Rischawy, F. 1; Wang, G.; Bauer, J.; Blech, M.; Kluters, S.; Studts, J.; Hubbuch, J. 1
1 Institut für Bio- und Lebensmitteltechnik (BLT), Karlsruher Institut für Technologie (KIT)


A vital part of biopharmaceutical research is decision making around which lead candidate should be progressed in early-phase development. When multiple antibody candidates show similar biological activity, developability aspects are taken into account to ease the challenges of manufacturing the potential drug candidate. While current strategies for developability assessment mainly focus on drug product stability, only limited information is available on how antibody candidates with minimal differences in their primary structure behave during downstream processing. With increasing time-to-market pressure and an abundance of monoclonal antibodies (mAbs) in development pipelines, developability assessments should also consider the ability of mAbs to integrate into the downstream platform. This study investigates the influence of amino acid substitutions in the complementarity-determining region (CDR) of a full-length IgG1 mAb on the elution behavior in preparative cation exchange chromatography. Single amino acid substitutions within the investigated mAb resulted in an additional positive charge in the light chain (L) and heavy chain (H) CDR, respectively. ... mehr

Verlagsausgabe §
DOI: 10.5445/IR/1000133875
Veröffentlicht am 14.06.2021
DOI: 10.1002/bit.27798
Zitationen: 3
Web of Science
Zitationen: 2
Zitationen: 3
Cover der Publikation
Zugehörige Institution(en) am KIT Institut für Bio- und Lebensmitteltechnik (BLT)
Publikationstyp Zeitschriftenaufsatz
Publikationsjahr 2021
Sprache Englisch
Identifikator ISSN: 0006-3592
KITopen-ID: 1000133875
Erschienen in Biotechnology and Bioengineering
Band 118
Heft 8
Seiten 2923-2933
Nachgewiesen in Dimensions
Web of Science
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