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Title

Analysis of recombinant monoclonal antibodies by RPLC: Toward a generic method development approach
Authors
Fekete, Szabolcs
Rudaz, Serge
Fekete, Jenő
Guillarme, Davy
Published in Journal of Pharmaceutical and Biomedical Analysis. 2012, vol. 70, p. 158-168
Abstract Monoclonal antibodies (mAbs) are an emerging class of therapeutic agents that have recently gained importance. To attain acceptable kinetic performance with mAbs in reversed phase liquid chromatography, there is a need to work with the last generation of wide-pore sub-2m fully porous or core–shell particles stationary phases. In addition, temperature in the range 60–90 ◦C was found to be mandatory to limit adsorption phenomenon of mAbs and their fragments. A generic method development strategy was proposed to account for the selectivity, efficiency, recovery, and the possible thermal degradation. This study also demonstrated that the gradient steepness and temperature cannot be optimized using van’t Hoff type linear models. Similarly, the common linear solvent strength model also generated some error in predicting the retention times. In contrast, when quadratic models were employed, the prediction accuracy of retention times was found to be excellent (relative error between 0.5 and 1%) using a reasonable number of experiments (9 or 6 experiments for optimization of gradient time and temperature, which requires between 6 and 8 h). Two separations of mAbs fragments were performed to demonstrate the reliability of the quadratic approach.
Keywords Monoclonal antibodies — Core–shell — UHPLC — DryLab — Method development — Optimization software
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Article (Published version) (1.3 MB) - document accessible for UNIGE members only Limited access to UNIGE
Other version: http://linkinghub.elsevier.com/retrieve/pii/S0731708512003536
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Faculté des sciences / Section des sciences pharmaceutiques
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(ISO format) 		FEKETE, Szabolcs et al. Analysis of recombinant monoclonal antibodies by RPLC: Toward a generic method development approach. In: Journal of Pharmaceutical and Biomedical Analysis, 2012, vol. 70, p. 158-168. https://archive-ouverte.unige.ch/unige:23653

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Deposited on : 2012-10-31

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