Deploying the Alliance™ iS Bio HPLC System as a Modern HPLC for Biopharmaceutical Analysis in QC Environments

The Alliance iS Bio HPLC System with MaxPeak™ High Performance Surfaces (HPS) Technology is a bio-inert LC 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 Technology, intuitive touchscreen operation, automated pre-run checks to minimize errors, and Intelligent Method Translator App (iMTA). Together, 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 biopharmaceuticals. Oligonucleotides were chosen as a test case given their relevance as an emerging modality and potential to benefit from the MaxPeak HPS Technology featured in the Alliance iS Bio HPLC System, given their susceptibility to analyte/surface interactions. In this study, up to a 30% increase in peak height and 15% increase in peak area was observed in the separation of oligonucleotides when compared to a legacy system. Furthermore, analysis run time, solvent, and sample consumption were reduced up to threefold when scaling to modern column chemistries. These results demonstrate the Alliance iS Bio HPLC System is well suited for QC environments as a next generation HPLC platform for analysis and routine testing of biopharmaceuticals.