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Modeling of bispecific antibody elution in mixed-mode cation-exchange chromatography.
Lee, Yi Feng; Kluters, Simon; Hillmann, Mirjam; von Hirschheydt, Thomas; Frech, Christian.
Afiliación
  • Lee YF; Institute of Biochemistry, University of Applied Sciences Mannheim, Mannheim, Germany.
  • Kluters S; Institute of Biochemistry, University of Applied Sciences Mannheim, Mannheim, Germany.
  • Hillmann M; Institute of Biochemistry, University of Applied Sciences Mannheim, Mannheim, Germany.
  • von Hirschheydt T; Roche Pharma Research and Early Development, Roche Innovation Center Munich, Penzberg, Germany.
  • Frech C; Institute of Biochemistry, University of Applied Sciences Mannheim, Mannheim, Germany.
J Sep Sci ; 40(18): 3632-3645, 2017 Sep.
Article en En | MEDLINE | ID: mdl-28714211
The increasing demand for cost-efficient manufacturing of biopharmaceuticals has been the main driving force for the development of novel chromatography resins, which resulted in the development of multimodal or mixed-mode chromatographic resins. Most of them combine electrostatic and hydrophobic functionalities and are designed to deliver unique selectivity and increased binding capacities also at increased ionic strength. However, the mechanism of the protein-resin interaction in mixed-mode chromatography is still not fully understood. The performance of protein separations in mixed-mode chromatography is consequently difficult to predict. In this work, we present a model combining both salt and pH dependence to characterize and to predict protein retention in mixed-mode chromatography. The model parameters are determined based on simple linear pH gradient elution experiments at different ionic strengths and they are directly transferable for the prediction of salt-induced elution at fixed pH. Validity of the model is demonstrated for a bispecific antibody and its product-related impurities.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cromatografía por Intercambio Iónico / Anticuerpos Biespecíficos Tipo de estudio: Prognostic_studies Idioma: En Revista: J Sep Sci Año: 2017 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Alemania
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cromatografía por Intercambio Iónico / Anticuerpos Biespecíficos Tipo de estudio: Prognostic_studies Idioma: En Revista: J Sep Sci Año: 2017 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Alemania