Computer assisted liquid chromatographic method development for the separation of therapeutic proteins

[en] This review summarizes the use of computer assisted liquid chromatographic method development for the analytical characterization of protein biopharmaceuticals. Several modes of chromatography including reversed-phase liquid chromatography (RPLC), ion exchange chromatography (IEX), hydrophobic interaction chromatography (HIC) and some perspectives are discussed. For all these chromatographic modes, the most important variables for tuning retention and selectivity are exposed. Then, the retention models that were applied in the literature in RPLC, IEX and HIC are described and critically discussed. Finally, some representative examples of separation of therapeutic proteins and mAbs are shown, to illustrate the possibilities offered by the retention modeling approach. At the end, the reliability of the models was excellent, whatever the chromatographic mode, and the retention time prediction errors were systematically below 2%. In addition, a significant amount of time can be saved during method development and robustness testing. © 2016 The Royal Society of Chemistry.

Disciplines :

Chemistry

Author, co-author :

Tyteca, Eva ; Université de Liège > Agronomie, Bio-ingénierie et Chimie (AgroBioChem) > Analyse, qual. et risques - Labo. de Chimie analytique

Veuthey, J.-L.; School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Boulevard d'Yvoy 20, Geneva 4, Switzerland

Desmet, G.; Vrije Universiteit Brussel, Department of Chemical Engineering, Pleinlaan 2, Brussels, Belgium

Guillarme, D.; School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Boulevard d'Yvoy 20, Geneva 4, Switzerland

Fekete, S.; School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Boulevard d'Yvoy 20, Geneva 4, Switzerland

Title :

Computer assisted liquid chromatographic method development for the separation of therapeutic proteins

Publication date :

2016

Journal title :

Analyst

ISSN :

0003-2654

eISSN :

1364-5528

Publisher :

Royal Society of Chemistry

Volume :

141

Issue :

Pages :

5488-5501

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 30 March 2017

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