Model‐Based Process Challenge of an Industrial Ion‐Exchange Chromatography Step
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Karin Westerberg | Bernt Nilsson | B. Nilsson | M. Degerman | T. B. Hansen | E. Broberg Hansen | M. Degerman | T. Budde Hansen | E. Hansen | Karin Westerberg
[1] Marcus Degerman,et al. A Model‐Based Approach to Determine the Design Space of Preparative Chromatography , 2009 .
[2] Lawrence X. Yu. Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control , 2008, Pharmaceutical Research.
[3] Marcus Degerman,et al. Model based robustness analysis of an ion-exchange chromatography step. , 2007, Journal of chromatography. A.
[4] K. Gernaey,et al. Good modeling practice for PAT applications: Propagation of input uncertainty and sensitivity analysis , 2009, Biotechnology progress.
[5] Niklas Jakobsson,et al. Designing robust preparative purification processes with high performance , 2008 .
[6] Marcus Degerman,et al. Modeling and optimization of preparative reversed-phase liquid chromatography for insulin purification. , 2007, Journal of chromatography. A.
[7] Marcus Degerman,et al. Determining Critical Process Parameters and Process Robustness in Preparative Chromatography - A Model-Based Approach , 2009 .
[8] Svend Havelund,et al. Quality by design - Spray drying of insulin intended for inhalation. , 2008, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[9] Marcus Degerman,et al. Optimisation and robustness analysis of a hydrophobic interaction chromatography step. , 2005, Journal of chromatography. A.
[10] Jon C. Helton,et al. Survey of sampling-based methods for uncertainty and sensitivity analysis , 2006, Reliab. Eng. Syst. Saf..
[11] Steven M. Cramer,et al. Steric mass‐action ion exchange: Displacement profiles and induced salt gradients , 1992 .
[12] Anita M. Katti,et al. Fundamentals of Preparative and Nonlinear Chromatography , 1994 .
[13] Arne Staby,et al. Quality by design--thermodynamic modelling of chromatographic separation of proteins. , 2008, Journal of chromatography. A.
[14] Jørgen Mollerup,et al. A review of the thermodynamics of protein association to ligands, protein adsorption, and adsorption isotherms , 2008 .
[15] Pedro Hernandez-Abad,et al. Quality by design case study: an integrated multivariate approach to drug product and process development. , 2009, International journal of pharmaceutics.
[16] J A Asenjo,et al. Application of chromatographic theory for process characterization towards validation of an ion‐exchange operation , 2007, Biotechnology and bioengineering.
[17] Diane J Burgess,et al. Quality by design approach to understand the process of nanosuspension preparation. , 2009, International journal of pharmaceutics.