Modernizing Compendial SEC Methods For Biotherapeutics Using The Alliance™ iS Bio HPLC System

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

Method modernization, a process involving incorporating advancements in system and column technology for routine analysis, presents a challenge for many regulated laboratories. This is largely due to the heightened emphasis from regulators on method life cycle management. While these labs often rely on validated methods from several years past that remain robust and effective, there is potential for improvement using faster, more robust, or more sensitive technologies.

To meet these evolving needs, Waters™ has launched the Alliance iS Bio HPLC System, a next-generation HPLC solution for biotherapeutics. This cutting-edge HPLC system features a bio-inert flow path and MaxPeak™ High Performance Surfaces (HPS) Technology, ensuring robust analysis for biopharmaceutical applications. While the Alliance iS Bio HPLC System retains the rugged reliability characteristic of legacy HPLC systems for daily operations, it introduces several innovative features including an intuitive touchscreen interface, automated pre-run checks, and method modernization tools integrated within the Empower™ Chromatography Data System (CDS) to mitigate common errors.

This application note explores the advantages of the Alliance iS Bio HPLC System through the migration and modernization of a compendial SEC method outlined in the United States Pharmacopeia (USP) General Chapter <129>. Utilizing this bio-inert HPLC system led to a significant reduction in solvent usage and shorter runtimes. Furthermore, compared to a traditional HPLC system, the Alliance iS Bio HPLC System demonstrated enhanced resolution and sensitivity towards size variant impurities.