Leveraging The Alliance™ iS Bio HPLC System As A Modern HPLC For Peptide Drug Substances Analysis In QC Environments

By Duanduan Han, Robert E. Birdsall, and Karen Nyholm

The Alliance iS Bio HPLC System, featuring MaxPeak™ High-Performance Surfaces (HPS) Technology, is a bio-inert liquid chromatography (LC) system developed to minimize surface/analyte interactions in biopharmaceutical manufacturing. This modern HPLC instrument features a large-volume mixer and reduced dispersion volume. When paired with MaxPeak Premier columns, this combination enables the modernization of methods, resource savings, and increased throughput in biopharmaceutical manufacturing. This study assesses the Alliance iS Bio HPLC System within a routine QC testing environment focused on peptide-size biopharmaceuticals.

The test cases selected include insulin, insulin analogs, glucagon, and GLP-1 peptides, as they are relevant in both traditional and novel diabetes treatments with weight management benefits. The study findings indicate that the Alliance iS Bio HPLC System is adept at executing established compendial methods while offering the flexibility to utilize modern column chemistries, thereby reducing operating costs. Compared to a legacy HPLC system, the Alliance iS Bio HPLC System proves to be highly suitable for QC environments, particularly for the analysis and routine testing of biopharmaceuticals.