Data is the common currency: What does it take to harmonize technologies and workflows across biopharmaceutical organizations?

Importance of the Topic

Harmonizing analytical technologies and workflows across biopharmaceutical organizations is essential to ensure consistent data quality, efficient method transfer and regulatory compliance. As biopharma pipelines become more complex and global, having standard approaches for chromatography, mass spectrometry and informatics helps reduce errors, improves reproducibility and accelerates decision making.

Objectives and Study Overview

This presentation from WCBP 2018 outlines a corporate strategy for harmonization of analytical methods. It reviews challenges in transferring methods and molecules between labs, introduces next-generation chromatography platforms and consumables, and describes workflows for protein and glycan analysis. Key goals include illustrating platform compatibility, demonstrating method transfer performance, and highlighting automation and data integration possibilities.

Methodology

Workflows include reversed-phase liquid chromatography for peptides, monoclonal antibodies and subunits; ultrahigh performance liquid chromatography (UHPLC) for high-resolution separations; and released N-glycan analysis with rapid labeling and clean-up kits. Comparative studies evaluated column chemistries at different particle sizes and inner diameters on HPLC, UHPLC and UPLC systems. Real-world case studies demonstrate method transfer between Waters Alliance HPLC, ACQUITY Arc Bio UHPLC and ACQUITY UPLC H-Class instruments.

Instrumentation Used

• Chromatography systems: Waters Alliance HPLC, ACQUITY Arc Bio UHPLC, ACQUITY UPLC H-Class (Bio/I-Class).
• Columns: XBridge BEH Peptide C18 (2.5 µm, 4.6 × 100 mm), BioResolve RP-mAb (2.7 µm, 4.6 × 50 mm), Glycan BEH Amide UPLC column.
• Detectors: UV/Vis, PDA, FLR, ACQUITY QDa, SQD2, QQQ, TOF and Q-Tof.
• Software: Empower 3, MassLynx, UNIFI Scientific Information System.
• Sample prep: GlycoWorks RapiFluor-MS N-Glycan kit; Andrew Alliance single-channel automation.

Key Results and Discussion

Comparative separations of peptides and mAb subunits showed that sub-2 µm particle columns on UPLC yield the highest resolution and peak capacity. Method transfer across platforms demonstrated consistent retention, resolution and peak area ratios for monoclonal antibody fragments. The BioResolve RP-mAb column provided high recovery and low carryover under low-pH conditions. Released N-glycan workflows achieved deglycosylation, labeling and clean-up in under 30 minutes, with FLR and MS detection sensitivity enabling high-throughput quantitation and structural confirmation.

Benefits and Practical Applications

• Improved method transferability reduces development time when moving between HPLC, UHPLC and UPLC.
• Biocompatible flow paths and solid core particles enhance robustness for protein separations.
• Rapid glycan labeling kits and automation scripts accelerate sample prep and minimize human error.
• Integrated informatics supports data consistency, compliance and streamlined reporting.

Future Trends and Opportunities

Continued evolution of column chemistries will target even larger biomolecules and higher throughput. Automation of sample prep on compact robotics will become more widespread, while cloud-based informatics and AI-driven method optimization promise to further harmonize workflows globally. Hybrid mass detectors combining quantitative and qualitative capabilities will enable richer datasets for biopharmaceutical characterization.

Conclusion

Effective harmonization of analytical technologies across biopharma organizations drives reproducible data, faster method deployment and higher productivity. The ACQUITY Arc Bio system, alongside complementary instrumentation and workflows, exemplifies how integrated strategies can meet current and future bioseparation challenges, ultimately supporting innovation and quality in drug development.