Model based robustness analysis of an ion-exchange chromatography step

Journal of Chromatography A

Volumn 1138, Issue 1-2, 2007, Pages 109-119

  Jakobsson, Niklas ^a   Degerman, Marcus ^a   Stenborg, Emelie ^a   Nilsson, Bernt ^a  

^a LUND UNIVERSITY   (Sweden)

Author keywords

Ion exchange chromatography; Modeling; Preparative chromatography; Process scale chromatography; Robustness analysis; Simulation; Validation

Indexed keywords

ADSORPTION; CHROMATOGRAPHIC ANALYSIS; MATHEMATICAL MODELS; OPTIMIZATION; PARAMETER ESTIMATION; SEPARATION;

ION EXCHANGE CHROMATOGRAPHY; PREPARATIVE CHROMATOGRAPHY; PROCESS SCALE CHROMATOGRAPHY; ROBUSTNESS ANALYSIS; VALIDATION;

ION EXCHANGE;

ADSORPTION KINETICS; ARTICLE; CALIBRATION; COLUMN CHROMATOGRAPHY; CONFIDENCE INTERVAL; CONTROLLED STUDY; ELUTION; FACTORIAL ANALYSIS; FLOW RATE; ION EXCHANGE CHROMATOGRAPHY; MASS ACTION; PH; PRIORITY JOURNAL;

CHROMATOGRAPHY, ION EXCHANGE; COMPUTER SIMULATION; HYDROGEN-ION CONCENTRATION; MODELS, THEORETICAL;

EID: 33845430022     PISSN: 00219673     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.chroma.2006.10.057     Document Type: Article

References (18)

1. Kelly B., Jennings D., and Wright P. Biopharmaceutics (1997) 36
2. Knaack C.A., and Hawrylechko A.M.J. Pharm. Sci. Tech. Today 7 (1998) 300
3. Eriksson L., Johansson E., Kettaneh-Wold N., Wikstöm C., and Wold S. Design of Experiments, Principles and Applications (2000), Learnways AB, Umeå p. 197
4. F.D.A. U.S Department of Health and Human Services, Guidence for Industry PAT-A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, 2004.
5. Karlsson D., Jakobsson N., Brink K.-J., Axelsson A., and Nilsson B. J. Chromatogr. A 1033 (2004) 71
6. Brooks C.A., and Cramer S.M. AIChE J. 38 (1992) 1969
7. Jakobsson N., Karlsson D., Axelsson J.P., Zacchi G., and Nilsson B. J. Chromatogr. A 1063 (2005) 99
8. Amersham Pharmacia Biotech, Ion-Exchange Chromatography-Principles and Methods, Amersham Pharmacia Biotech AB, Uppsala, 1999.
9. Bosma J.C., and Wesselingh J.A. AIChE J. 44 (1998) 2399
10. Qinghong S., Ying Z., and Yan S. Biotechnol. Progr. 21 (2005) 516
11. Persson P., Kempe H., Zacchi G., and Nilsson B. Chem. Eng. Res. Des. 82 A2 (2004) 1
12. Persson P. Calibration of Chromatography Models, Chemical Engineering (2004), Lund University
13. Wilson C. Applied Statistics for Engineers (1972), Gilliard Limited, Norfolk, England
14. Seely R.J., Hutchins H., and Lucher V.M.P. Biopharmaceutics (1999) 33
15. Wolk B., Bezy P., Arnold R., and Blank G. Bioprocess Int. 1 (2003) 50
16. Gadam S.D., Jayaraman G., and Cramer S.M. J. Chromatogr. 630 (1993) 37
17. Guiochon G., Golshan-Shirazi S., and Katti A.M. Fundamentals of Preparative and Nonlinear Chromatography (1994), Academic Press Limited, London
18. Process Systems Enterprise Ltd., gPROMS advanced user guide, Process Systems Enterprise Ltd., London, 2001.