Quality Control Application For Therapeutic Proteins

By Chantal Felten, Alpine Analytical Academy and Oscar Salas Solano, Seattle Genetics

A decade ago, Capillary Electrophoresis (CE) was considered a novelty. Today it is commonly used in quality control worldwide, providing automated, high-resolution methods, with online detection. In the first part of this series of articles, we will illustrate an overview of CE in a modern quality control laboratory. The complete series of articles will address in depth the following: Applications in QC; CE-SDS (sodium dodecyl sulfate) method development and robustness; Application of ICH Q2 (R1) to CE and finally successful CE method lifecycle management, i.e. training, transfer and method replacement.