High Throughput Screening for the Design and Optimization of Chromatographic Processes – Miniaturization, Automation and Parallelization of Breakthrough and Elution Studies

• DOI: 10.1002/ceat.200800167
• Publication Date: 2008-05-27T10:46:22Z
• Authors: M. Wiendahl; P. Schulze Wierling; J. Nielsen; D. Fomsgaard Chri...; J. Krarup; A. Staby; J. Hubbuch
• Keywords: Quality by Design; Scale-up

Abstract This study evaluates the applicability of liquid handling workstation Tecan Evo Freedom 200 and μL Media Scout RoboColumns to dynamic chromatographic operations such as frontal analysis (breakthrough) elution experiments in a high throughput screening mode. Breakthrough were conducted using BSA model protein stationary phases Poros 50 D, Q Ceramic HyperD DEAE Sepharose FF. The obtained capacities at 10 % breakthrough matched well with reference data. Elution performed applying three mixtures: a) lipolase BSA, b) human growth hormone process‐related impurity, c) an insulin analogue impurity. resins used resembled variety different ion exchange resins. In all cases, resulting curves measurements on ÄKTA explorer system 1 mL or 2 scale.