| 摘要 |
A method for determination of chromatography conditions for separation of a biomolecule from a liquid sample, comprising: a) selecting a number of experiments using Design of Experiments (DoE); performing said experiments with in-line conditioning of at least two gradients of two selected quality measures (process variables); and c) based on the results of said experiments, determining efficient chromatography conditions for the biomolecule, where the experiments selected use at least two orthogonal (different/independent) quality measures. Preferably the quality measures (process variables) are selected from: type of chromatography resin; loading volume; wash volume; elution volume; binding buffer; elution buffer; surface determinant of the biomolecule; and impurities present in the liquid sample. Preferably the in-line conditioning comprises conditioning of a liquid sample to a predetermined pH and/or conductivity. Also claimed is a system for the determination of chromatography conditions for separation of a biomolecule from a liquid sample. |
