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, firstname.lastname@example.org
. Rick Schreurs is group leader of the section, and Anke Gijsen and Kees Verhoeven are research technicians.
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