Use of quality by the design for the modelling of chromatographic separations

Journal of Liquid Chromatography and Related Technologies

Volumn 32, Issue 11-12, 2009, Pages 1577-1597

  Mollerup, Jørgen M ^a   Hansen, Thomas Budde ^b   Kidal, Steffen ^b   Sejergaard, Lars ^a   Hansen, Ernst ^b   Staby, Arne ^b  

^a Prepchrom ^*  (Denmark)

^b NOVO NORDISK A S   (Denmark)

Author keywords

Association; Isotherm; Model; Preparative chromatography; Protein; Quality by design

Indexed keywords

ASSOCIATION; CHROMATOGRAPHIC SEPARATIONS; DESIGN SPACES; MANUFACTURING PROCESS; PREPARATIVE CHROMATOGRAPHY; PROCESS DEVELOPMENT; PROCESS UNDERSTANDING; QUALITY BY DESIGN; SCIENTIFIC PRINCIPLES;

CHROMATOGRAPHIC ANALYSIS; CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; ISOTHERMS; PROCESS ENGINEERING;

DESIGN;

ADSORPTION CHROMATOGRAPHY; ANALYTIC METHOD; ARTICLE; CHROMATOGRAPHY; ISOTHERM; MATHEMATICAL MODEL; PARAMETER; PARTITION COEFFICIENT; PROCESS DESIGN; PROCESS DEVELOPMENT; PROTEIN PROTEIN INTERACTION; QUALITY CONTROL; REPRODUCIBILITY; SENSITIVITY ANALYSIS; SEPARATION TECHNIQUE;

EID: 70349739261     PISSN: 10826076     EISSN: 1520572X     Source Type: Journal    
DOI: 10.1080/10826070902956345     Document Type: Article

References (19)

1. Guidance for Industry. PAT-A framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, US Department of Health and Human Services, Food and Drug Administration (FDA), Centre for Drug Evaluation and Research (CDER), Centre for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), September, 2004.
2. ICH Harmonised Tripartite Guideline, Pharmaceutical Development Q8, Current Step version 4, November 2005. Draft Consensus Guideline, Pharmaceutical Development Annex to Q8, Current Step version 2, November, 2007.
3. Yu, L.X. Pharmaceutical quality by design: Product and process development, understanding, and control. Pharmaceut. Res. 2008, 25, 781-791.
4. Mollerup, J.M. A review of the thermodynamics of protein association to ligands, protein adsorption, and adsorption isotherms. Chem. Eng. Technol. 2008, 31, 864-874.
5. Mollerup, J.M. The thermodynamic principles of ligand binding in chromatography and biology. J. Biotechnol. 2007, 132, 187-195. (Pubitemid 47599706)
6. Bensch, M.; Wierling, P.S.; von Lieres, E.; Hubbuch, J. High throughput screening of chromatographic phases for rapid process development. Chem. Eng. Technol. 2005, 28, 1274-1284.
7. Mollerup, J.M.; Hansen, T.B.; Kidal, S.; Sejergaard, L.; Staby, A. Development, modelling, optimisation and scale-up of chromatographic purification of a therapeutic protein. Fluid Phase Equil. 2007, 261, 133-139.
8. Kidal, S.; Jensen, O.E. Using volumetric flow to scale-up chromatographic processes. BioPharm. Intl. 2006, (March), 34-43.
9. Hagel, L.; Jagschies, G.; Sofer, G. Handbook of Process Chromatography, Development, Manufacturing, Validation and Economics, Chapters 6 and 7, 2nd Ed.; Academic Press, 2008.
10. Guiochon, G.; Felinger, A.; Shirazi, D.G.G. Fundamentals of Preparative and Nonlinear Chromatography, Chapter 7, 2nd Ed.; Academic Press, 2006.
11. Pedersen, L.; Mollerup, J.M.; Hansen, E.; Jungbauer, A. Whey proteins as a model system for chromatographic separation of proteins. J. Chromatogr. B. 2003, 790, 161-173.
12. Mollerup, J.M.; Hansen, T.B.; Kidal, S.; Staby, A. Quality by design - thermodynamic modelling of chromatographic separation of proteins. J. Chromatogr. A. 2008, 1177, 200-206.
13. McCue, J.T; Engel, P.; Ng, A.; Macniven, R.; Thömmes, J. Modeling of protein monomer=aggregate purification and separation using hydrophobic interaction chromatography. Bioproc. Biosyst. Eng. 2008, 13, 261-275.
14. Chen, J.; Yang, T.; Cramer, S.M. Prediction of protein retention times in gradient hydrophobic interaction chromatographic systems, J. Chromatogr. A. 2008, 1177, 207-214.
15. Rathore, A.S.; Sharma, A.; Chilin, D. Applying process analytical technology to biotech unit operations. BioPharm Intl. 2006, 19 (8), 48-57. (Pubitemid 44232257)
16. Kaltenbrunner, O.; McCue, J.; Engel, P.; Mollerup, J.M.; Rathore, A.S. Modeling of biopharmaceutical processes: II. Process chromatography unit operation. BioPharm Intl. 2008, 21 (8), 28-42.
17. Kaltenbrunner, O.; Giaverini, O.; Woehle, D.; Asenjo, J.A. Application of chromatographic theory for process characterization towards validation of an ion-exchange operation. Biotechnol. Bioeng,. 2007, 98, 201-210.
18. Rathore, A.S.; Yu, M.; Yeboah, S.; Sharma, A. Case study and application of Process Analytical Technology (PAT) towards bioprocessing: Use of on-line High-Performance Liquid Chromatography (HPLC) for making real-time pooling decisions for process chromatography. Biotechnol. Bioeng. 2008, 100, 306-316.
19. Brooks, C.A.; Cramer, S.M. Steric mass-action ion exchange: Displacement profiles and induced salt gradients. AIChE J. 1992, 38, 1969-1978.