Modeling of Biopharmaceutical Processes. Part 2: Process Chromatography Unit Operation - How to apply the latest thinking in process modeling to your process using a Quality by Design approach. - BioP

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Modeling of Biopharmaceutical Processes. Part 2: Process Chromatography Unit Operation
How to apply the latest thinking in process modeling to your process using a Quality by Design approach.


BioPharm International
Volume 21, Issue 8

CONCLUSION AND RECOMMENDATIONS


Table 3. Comparison of simulated and experimental results from an optimization.4
Simulations can be used to identify critical process parameters and support process design and development by making a true optimization with regard to pressure drop, flow rate, gradients, salt, pH, temperature, throughput, yield, purity, and robustness. Applying these modeling tools in the development of chromatographic separations can support the design of effective and efficient manufacturing processes that will consistently ensure a predefined quality at the end of the manufacturing process, consistent with the basic tenet of Quality by Design.

REFERENCES:

1. McCue JT, Engel P, Ng A, Macniven R, Thömmes J. Modeling of protein monomer/aggregate purification and separation using hydrophobic interaction chromatography. Bioprocess Biosystems Eng. 2008;31:261–275.

2. Kaltenbrunner O, Giaverini O, Woehle D, Asenjo JA. Application of chromatographic theory for process characterization towards validation of an ion-exchange operation, Biotechnol Bioeng. 2007;98:201–210.

3. Mollerup JM, Hansen TB, Kidal S, Staby A. Quality by Design—Thermodynamic modelling of chromatographic separations of proteins. J Chromatogr A. 2008;1177:200–206.

4. Mollerup JM, Hansen TB, Kidal S, Sejergaard L, Staby A. Development, modeling, optimization and scale-up of chromatographic purification of a therapeutic protein. Fluid Phase Liquid Equilib. 2007;261:133–139.

5. Rathore AS, Sharma A, Chilin D. Applying process analytical technology to biotech unit operations. BioPharm Int. 2006;8:48–57.

6. Seely RJ, Haury J. Applications of failure modes and effects analysis to biotechnology manufacturing processes. In: Rathore AS, Sofer G, editors. Process validation in manufacturing of biopharmaceuticals. Boca Raton: Taylor & Francis; 2005. p. 13–30.

7. Seely, J. Process characterization. Process validation in manufacturing of biopharmaceuticals. Boca Raton: Taylor & Francis; 2005. p. 31–68.

8. Weaver LE, Carta G. Protein adsorption on cation exchangers: comparison of macroporous and gel composite media. Biotechnol Prog. 1996;12:342.

9. Langmuir I. The adsorption of gases on plain surfaces of glass, mica, and platinum. J Am Chem Soc. 1918;40:1361.

10. Brooks CA, Cramer SM. Steric mass-action ion exchange: displacement profiles and induced salt gradients. AIChE Journal. 1992;32:1969.

11. McCue JT, Kemp G, Low D, Quiñones-Garcia. Evaluation of protein-A chromatography media. J. Chromatogr. A. 2003;989:139.

12. Lewus, RK, Carta G, Binary protein adsorption on gel-composite ion-exchange media. AIChE Journal. 1999;45:512.

13. Yamamoto S, Nakanishi K, Matsuno R. Ion-exchange chromatography of proteins. In: J. Cazes, editor. Chromatographic Science Series. New York: Marcel Dekker; 1988. vol. 43.

14. Watler P, Yamamoto S, Kaltenbrunner O, Feng D. Engineering aspects of ion-exchange chromatography. In: Rathore AS, Velayudhan A, editors. Scale-up and optimization on preparative chromatography. New York: Marcel Dekker, Inc.; 2003.

Oliver Kaltenbrunner is a principal scientist at Amgen, Inc., Thousand Oaks, CA. Justin McCue is a senior engineer and Philip Engel is a scientist of process development at Biogen Idec Corporation, Cambridge, MA. Jorgen M. Mollerup teaches at Department of Chemical and Biochemical Engineering, Technical University of Denmark, Lyngby, Denmark. Anurag S. Rathore, PhD, is a director of process development at Amgen, Inc., Thousand Oaks, CA, 805.447.4491,
He is also a member of BioPharm International's Editorial Advisory Board.


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