Downstream Processing: Platform Technology for Developing Purification Processes - - BioPharm International

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Downstream Processing: Platform Technology for Developing Purification Processes


BioPharm International
Volume 20, Issue 3


Figure 8B
The results in Figure 8A clearly show the effects of the main parameters—pH,conductivity, salt—in the loading (elution) phase over a broad range around the standard operating ranges. The outcome of these studies can be used to set or restrain limits for certain critical parameters that may influence or become critical in this specific purification step. Moreover, optimization in terms of interaction effects, as shown in Figure 8B (interaction between pH in loading phase and conductivity in the elution phase) indicate that not only are the main parameters important, but their interactions are, too.

Finally, this platform technology shows that a structural approach for setting up a downstream process (for each purification step) is feasible. Speed, understanding, and robustness may aid in the use of this platform technology as a very useful approach for every downstream process in development.

Michel Eppink is director of the downstream processing methodology and troubleshooting section of the API/biotech division at NV Organon, Oss, The Netherlands, +31 412 665850,
. Rick Schreurs is group leader of the section, and Anke Gijsen and Kees Verhoeven are research technicians.

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4. Merchant M, Weinberger SR. Recent advancements in surface-enhanced laser desorption/ionization-time of flight-mass spectrometry. Electrophoresis 2000;21: 1164–77

5. Weinberger SR, Viner RI, Ho P. Tagless extraction-retentate chromatography: A new global protein digestion strategy for monitoring differential protein expression. Electrophoresis 2002;23:3182–92.

6. Seibert V, Ebert MPA, Buschmann T. Advances in clinical cancer proteomics: SELDI–T–of-mass spectrometry and biomarker discovery. Br Funct Genomics and Proteomics 2005;4:16–26.

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8. Montgomery DC. Design and Analysis of Experiments. New York, NY: Wiley & Sons, Inc; 2001.


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