Leveraging the Alliance™ iS Bio HPLC System as a Modern HPLC for Peptide Drug Substances Analysis in QC Environments

The Alliance iS Bio HPLC System with MaxPeak™ High Performance Surfaces (HPS) Technology is a bio-inert liquid chromatography (LC) system designed to reduce surface/analyte interaction for biopharmaceutical manufacturing environments. As a modern HPLC instrument, the Alliance iS Bio HPLC System is engineered with features including Waters innovative MaxPeak HPS, lower dispersion volume, and a large volume mixer.
Together with MaxPeak Premier columns, these features enable manufacturing environments to modernize methods, save resources, and increase throughput for biopharmaceuticals. In this study, we evaluate the Alliance iS Bio HPLC System in a routine QC testing environment for peptide-size biopharmaceuticals.

Insulin, insulin analogs, glucagon, and GLP-1 peptides were chosen as test cases given their relevance as classic and new treatment of diabetes with benefits of weight management. The study results demonstrate the Alliance iS Bio HPLC System is capable of running legacy compendial methods while allowing users the flexibility to take advantage of modern column chemistries to reduce operating costs. When compared against a legacy HPLC system, results demonstrate the Alliance iS Bio HPLC System is well suited for QC environments in the analysis and routine testing of biopharmaceuticals.