CMO/CDMO Automates Glycan Workflows to Increase Business Capacity

Significance of the Topic

Glycosylation is a critical quality attribute for biotherapeutics, directly influencing efficacy, safety, and consistency. Efficient glycan profiling is essential for drug development, regulatory compliance, and ensuring uniform product quality across manufacturing batches.

Objectives and Study Overview

KBI Biopharma Inc. aimed to automate and streamline its released glycan analysis workflow to meet growing client demand and regulatory requirements. By implementing the Waters UNIFI Scientific Information System and GlycoWorks RapiFluor-MS kit on a Xevo G2-XS QTof mass spectrometer, the company sought to increase throughput, improve compliance with 21 CFR Part 11 and cGMP, and enhance data integrity.

Methodology and Instrumentation

The workflow integrated UltraPerformance Liquid Chromatography–Mass Spectrometry (UPLC–MS) with automated data acquisition, processing, and reporting. Key components included:

• Waters Xevo G2-XS QTof Mass Spectrometer
• Waters UNIFI Scientific Information System for unified data handling and compliance
• GlycoWorks RapiFluor-MS kit for rapid fluorescent labeling of released glycans
• ACQUITY UPLC H-Class system for high-resolution separations

Main Results and Discussion

Adoption of the UNIFI platform and RFMS workflow led to significant productivity improvements. Data processing and identification of glycan species were automated, reducing manual calculations and database lookups. Preliminary estimates indicate a 50–80% reduction in analysis time compared to legacy procainamide methods. The integrated reporting tools accelerated report generation and enabled consistent data sharing among internal teams and external clients.

Benefits and Practical Applications

The automated workflow delivered multiple benefits:

• Faster decision-making due to rapid access to processed results
• Enhanced regulatory compliance through built-in audit trails and electronic records
• Improved laboratory efficiency, enabling broader staff participation and reduced training time
• Scalable capacity to support increasing project volumes in glycan profiling

Future Trends and Potential Uses

Further expansion of UNIFI workflows may include biopharmaceutical applications such as intact protein and peptide mapping, metabolite identification, and forensic toxicology. Integration with cloud-based data management, advanced data mining, and machine learning algorithms is anticipated to drive even higher levels of automation and deeper analytical insights.

Conclusion

The implementation of the Waters UNIFI platform combined with the GlycoWorks RapiFluor-MS kit on a Xevo G2-XS QTof system effectively automated KBI Biopharma’s glycan profiling workflows. This advancement improved throughput, ensured regulatory compliance, and positioned the company to address future analytical challenges in biopharmaceutical development.

Reference

• Waters Corporation. CMO/CDMO Automates Glycan Workflows to Increase Business Capacity. May 2019.