Increasing Consistency Across Biopharmaceutical Labs with the ACQUITY Premier LC Platform

Significance of the topic

This study addresses the critical need for reproducible analytical results across biopharmaceutical laboratories when migrating chromatographic assays. Consistent data continuity and regulatory compliance depend on minimizing variability in retention time, peak area, and glycan identification. The ACQUITY Premier LC platform with MaxPeak High Performance Surfaces offers improved handling of metal-sensitive analytes to support reliable cross-lab comparisons.

Objectives and study overview

The work evaluated whether two configurations of the ACQUITY Premier LC System could replicate a legacy HILIC-based glycan profiling method. A released glycan performance standard was analyzed on both a BioAccord system with waters_connect and an Empower 3 system with QDa detection. Key metrics included chromatographic profiles, relative peak areas, retention times, and glucose unit (GU) values.

Methodology

• Standard: RapiFluor-MS Glycan Performance Test.
• Column: ACQUITY Premier Glycan BEH Amide, 1.7 µm, 130 Å, 2.1 × 150 mm.
• Gradient: 35 min at 0.6% B/min under HILIC conditions.
• Detection: fluorescence and orthogonal mass spectrometry (QDa).
• Evaluation: relative peak area percentages, retention time shifts, GU comparisons.

Instrumentation used

• Two ACQUITY Premier LC systems.
• BioAccord LC-MS with waters_connect informatics.
• Empower 3 CDS paired with ACQUITY QDa Mass Detector.

Main results and discussion

Chromatograms from both platforms showed highly comparable peak intensities and glycan species. Relative peak area differences were below 0.5%, and retention time offsets averaged 0.08 min. GU values calculated via a dextran ladder aligned within 0.1 units of legacy library entries. Orthogonal QDa data confirmed the identity of the FA2G2 glycan at m/z 1051, corresponding to GU 7.44.

Benefits and practical applications

• Reliable method transfer between development and supporting labs.
• Seamless compatibility with existing GU libraries and scientific databases.
• Reduced analyte–surface interactions for metal-sensitive species.
• Consistent monitoring of critical quality attributes.

Future trends and potential applications

Future developments may extend MaxPeak HPS technology to a broader range of analytes and instrument platforms. Integration with automated QC workflows and advanced data analytics could further streamline cross-platform standardization. Enhanced informatics connectivity may enable real-time normalization and global comparability of analytical methods.

Conclusion

The ACQUITY Premier LC System delivers robust, cross-instrument reproducibility for HILIC glycan assays while matching legacy performance. Its consistent retention, peak area, and GU results support rigorous biopharmaceutical development and manufacturing workflows.

References

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• Zhang X et al. Increasing Productivity and Confidence for N-linked Glycan Analysis of Biosimilars Using the BioAccord System. Waters Application Note. 2019.
• Zhang X, Kellett J, Birdsall R, Yu Y. Improving Released N-Glycan Analysis Using the ACQUITY Premier Solution with MaxPeak HPS Technology. Waters Application Note. 2021.