Capillary Electrophoresis in Quality Control.pdfVIP

Capillary Electrophoresis in Quality Control: PART I: Application for Therapeutic Proteins Blood Banking 1 2 Chantal Felten* and Oscar Salas Solano Capillary Electrophoresis Centrifugation *Consulting author Flow Cytometry 1 2 Alpine Analytical Acadamy, Whistler, British Columbia Seattle Genetics, Bothell, WA Genomics Lab Automation Lab Tools Particle Characterization Abstract identity, purity and composition of a drug A decade ago, Capillary Electrophoresis CE was substance and drug product. considered a novelty. Today it is commonly used in quality control worldwide, providing automated, high-resolution This article describes the advantages of three methods, with online detection. In the first part of this CE applications for the analysis of protein-based series of articles, we will illustrate an overview of CE pharmaceuticals. The first application illustrates in a modern quality control laboratory. The complete the application and advantages of a generic and series of articles will address in depth the following: quantitative CE-SDS assay with UV and or laser- Applications in QC; CE-SDS sodium dodecyl sulfate induced fluorescence LIF detection to assess the size method development and robustness; Application of heterogeneity of protein products. The second section ICH Q2 R1 to CE and finally successful CE method focuses on the use of capillary isoelectric focusing CIEF lifecycle management, i.e. training, transfer and method to determine charge heterogeneity of protein products. replacement. Finally, given the growing importance of glycosylation characterization, we will review the application of capillary Electrophoretic techniques such as SDS IEF gels have traditionally been part of release testing MS detection for complex glycoprotein analysis. in the biopharmaceutical industry. However, these slab gel methods are inconvenient, use toxic reagents, exhibit CE-SDS for Analysis of Therapeutic Proteins high intra- and inter- gel effective mobility var