Evaluating The Ruggedness Of The Alliance™ iS Bio HPLC System For SEC Separations

By Pawel Bigos, Robert E. Birdsall, and Karen Nyholm

Biopharmaceutical companies frequently advance multiple monoclonal antibody (mAb) drug candidates to minimize the risks inherent in drug development. This strategic approach aims to increase the chances of success and is often supported by the adoption of advanced technologies to enhance the efficiency and effectiveness of laboratory operations, ultimately driving the most promising candidates forward.

In quality control (QC) environments, implementing robust methods is crucial for ensuring the precision, accuracy, and reliability of results to enable informed decision-making throughout the manufacturing process. A vital aspect of these methodologies is identifying the appropriate instrumentation and columns for the selected analytical method. For instance, in size exclusion chromatography (SEC), considerations such as the type of stationary phase, instrument dispersion, column dimensions, ionic strength, and pH tolerance are important. Waters has introduced the Alliance iS Bio HPLC System, a next-generation HPLC system tailored for the robust analysis of biopharmaceutical applications. Featuring biocompatible, highly inert construction and MaxPeak™ High-Performance Surfaces (HPS) Technology, this system is designed to reduce analysis variability. In this application note, the robustness advantages provided by this surface technology in SEC separations will be evaluated.