Deploying The Alliance™ iS Bio HPLC System As A Modern HPLC For Biopharmaceutical Analysis In QC Environments

By Xiangsha Du, Robert E. Birdsall, Pawel Bigos, Duanduan Han, and Karen Nyholm

The Alliance iS Bio HPLC System, engineered with MaxPeak™ High Performance Surfaces (HPS) Technology, offers a bio-inert LC designed to minimize surface/analyte interactions in biopharmaceutical manufacturing environments. This modern HPLC instrument features user-friendly touchscreen controls, automated pre-run checks for error minimization, and the Intelligent Method Translator App (iMTA). Together, these components enable manufacturers to modernize methods, conserve resources, and boost throughput for biopharmaceuticals.

In this study, the performance of the Alliance iS Bio HPLC System in a routine QC testing environment specific to biopharmaceuticals is evaluated. Oligonucleotides were selected as a test case due to their relevance as an emerging modality and potential advantages from the MaxPeak HPS Technology, given their surface/analyte interaction susceptibility. Study findings revealed a notable improvement in peak height and peak area in the separation of oligonucleotides in comparison to a legacy system and demonstrated the suitability of this next-generation HPLC platform for the analysis and routine testing of biopharmaceuticals in QC environments.