A procedure for designing the operation parameter space for the twin-column multicolumn countercurrent solvent gradient purification (MCSGP) process for the purification of therapeutic proteins is derived. This is based on the equilibrium theory, which assumes instantaneous equilibrium conditions. As the MCSGP process allows protein separation with a linear modifier gradient, all equations are derived in terms of the covered distance as a function of the modifier concentration in ion-exchange chromatography. All constraints, which need to be fulfilled in order to obtain a stable process with maximum yield and purity, are described as a function of the different process parameters. For operation parameters within the parameter space where all constraints are fulfilled, a stable process is predicted. Additionally, on the boundary of this region, the optimal operation point in terms of buffer consumption and productivity can be found. Besides, the presented design space can help to analyze the impact of different process parameters on performance and stability and therefore to establish conditions for a robust operation of the process.
|Titolo:||Equilibrium Theory Based Design Space for the Multicolumn Countercurrent Solvent Gradient Purification Process|
|Data di pubblicazione:||2017|
|Appare nelle tipologie:||01.1 Articolo in Rivista|