Pushing the Edge... With All Deliberate Speed

Importance of the Topic

Biopharmaceutical research and manufacturing are experiencing rapid growth, driven by novel therapeutic modalities and personalized medicine. This momentum places increasing pressure on analytical laboratories to deliver high-quality data faster, ensure regulatory compliance, and support continuous manufacturing workflows. Harmonized, fit-for-purpose analytical platforms and streamlined data handling are key to meeting these productivity and quality challenges across discovery, development, and commercial operations.

Objectives and Overview of the Presentation

The primary goal of this Waters Corporation presentation is to outline a strategic vision for harmonizing analytical workflows in the biopharma sector. Key objectives include:

• Presenting industry trends that demand greater productivity, such as biosimilars and complex molecules.
• Describing Waters’ comprehensive portfolio of mass spectrometry and chromatography tools.
• Detailing how an integrated informatics environment preserves data integrity and accelerates method transfer.
• Sharing highlights from ASMS 2018 activities, seminars, and posters to illustrate real-world applications.

Methodology and Used Instrumentation

Waters proposes a “fit-for-purpose” deployment of mass spectrometry across non-regulated discovery to regulated QC:

• High-resolution platforms (Synapt G2 Si, VION HDMS) for advanced characterization.
• Compact QDa detectors integrated with ACQUITY UPLC for routine monitoring in GMP environments.
• UNIFI software ecosystem to manage data acquisition, method transfer, validation, and archival with audit trails.
• GlycoWorks RapiFluor-MS kits for rapid released N-glycan labeling, with manual and automated workflows on Hamilton and Andrew Alliance platforms.
• Additional hardware including column heaters, microtiter plate autosamplers, binary pumps, and UV detectors for multi-attribute monitoring (MAM) assays.

Main Results and Discussion

Workflows presented at ASMS 2018 demonstrate:

• Native SEC-MS enhancements deliver improved spectral clarity for intact protein complexes.
• QDa-based Selected Ion Recording (SIR) enables simultaneous monitoring of peptide glycoforms, oxidation, deamidation, and C-terminal clipping in a single run.
• Automation of sample preparation scales released N-glycan analysis from 8 to 96 samples with high reproducibility.
• MAM methods in UNIFI achieve comparable performance using MS and MSE acquisition modes, bridging discovery and QC analytics.
• Interoperability with third-party software (Mascot, ProSight) allows downstream data mining and PTM identification.

Benefits and Practical Applications of the Method

These integrated workflows provide:

• Enhanced laboratory productivity via consolidated hardware and software platforms.
• Robust data integrity and audit readiness for GLP/GMP submissions.
• Reduced method transfer risk through harmonized informatics and standardized consumables.
• Scalable automation options to meet fluctuating throughput demands in biopharma labs.
• Comprehensive attribute monitoring for QC of monoclonal antibodies, ADCs, peptides, and oligonucleotides.

Future Trends and Opportunities

Looking ahead, the industry is expected to adopt:

• Continuous manufacturing integrated with real-time analytical monitoring (PAT) to shorten time-to-market.
• Further miniaturization and cost-reduction of mass detectors for broader accessibility.
• Cloud-enabled informatics and AI-driven data analysis to accelerate decision-making.
• Stronger regulatory alignment on data standards and electronic batch records.
• Expanded automation beyond sample prep into fully autonomous analytical workflows.

Conclusion

Waters’ multi-dimensional innovation strategy addresses the evolving demands of biopharmaceutical analysis by delivering a unified, compliance-ready ecosystem of instruments, software, and consumables. This approach empowers laboratories to increase throughput, ensure data integrity, and streamline method lifecycle management across drug discovery, development, and manufacturing.

Reference

1. Waters Corporation. “Pushing the Edge… With All Deliberate Speed.” ASMS 2018 Presentation. June 2018.
2. Global Industry Analysts, Inc. “Pharma Industry Forecast – 2020.”
3. Neil S. “Pharma Catches on to Continuous Manufacturing.” Automation World, December 6 2017.