Modernizing Compendial SEC Methods for Biotherapeutics Using the Alliance™ iS Bio HPLC System

The process of method modernization, which involves integrating advancements in system and column technology for routine analysis, is a challenge many regulated laboratories face due to a larger focus on method life cycle management from regulators. Regulated laboratories often rely on methods that were validated several
years ago and while still robust and effective, improvement opportunities could be identified, evaluated, and replaced with faster, more robust, or more sensitive technology. To address these demands, Waters™ has introduced the next generation of HPLC for biotherapeutics, the Alliance iS Bio HPLC System. This next generation HPLC was designed with a bio-inert flow path and MaxPeak™ High Performance Surfaces (HPS) Technology for robust analysis of biopharmaceutical applications. While the Alliance iS Bio HPLC System maintains the identity of legacy HPLC systems as a rugged and reliable “workhorse” for daily operation, it is also designed with several new key features such as an intuitive touchscreen control, pre-run checks, and method modernization tools within Empower™ Chromatography Data System (CDS) to reduce common errors. In this application note, we’ll assess the benefits of the Alliance iS Bio HPLC System by migrating and modernizing a compendial SEC method outlined in the United States Pharmacopeia (USP) General Chapter <129>. By deploying this next-generation bio-inert HPLC system, a significant decrease in solvent consumption and a shorter runtime was observed. Additionally, the Alliance iS Bio HPLC System exhibited an increase in resolution and sensitivity towards size variant impurities in comparison to a legacy HPLC system.