Scientific Article: Comprehensive Biopharmaceutical Structural Characterization with High-Resolution Mass Spectrometry

In the rapidly evolving biopharmaceutical industry, staying at the forefront of analytical technology is essential for delivering high-quality structural characterization data that regulatory authorities and clients demand. At BioPharmaSpec, our commitment to analytical excellence has led us to adopt the latest innovations in mass spectrometry to meet the growing complexity of modern biopharmaceuticals.

Our Jersey, UK, laboratory recently became the first customer globally to implement the Waters Xevo MRT MS for biopharmaceutical work. This instrument is a state-of-the-art, multi-reflecting, time-of-flight mass spectrometer that delivers exceptional resolution and mass accuracy. This case study, developed in collaboration with Waters, demonstrates how Waters Xevo MRT MS is enhancing our analytical capabilities and accelerating our client’s drug development programs. The partnership builds on our longstanding relationship with Waters, dating back to Chairman Prof. Howard Morris' involvement in the original Q-TOF design.

The Xevo MRT MS achieves 100,000 FWHM resolution with sub-ppm mass accuracy, allowing our scientists to perform greater in-depth analysis of complex samples. This enhanced capability is particularly valuable for characterizing heavily glycosylated glycoproteins, oligonucleotides, and other complex molecules that require detailed investigation of post-translational modifications and product heterogeneity.

Key Benefits of the Xevo MRT MS highlighted: 

• Superior Resolution: Distinguishes between similar masses and allows for accurate mass measurements.
• Enhanced Glycan Analysis: Provides in-depth characterization of glycosylation patterns.
• Improved Efficiency: Integration with waters_connect Software enables faster data processing and earlier decision-making in analytical workflows.
• Expanded Capabilities: Supports our growing portfolio of services for diverse biopharmaceutical products and emerging modalities.

As Dr. Richard Easton, Technical Director of Structural Analysis, explains in the case study: "BioPharmaSpec leverages state-of-the-art mass spectrometers and techniques to deliver comprehensive structural analysis that meets ICH Q6B guidelines. The Xevo MRT MS exemplifies this commitment, enabling us to build quality through knowledge and provide our clients with deeper understanding of their biopharmaceutical products." Michael-John O’Connor, Director of Biochemical Services, further reflects on its impact, stating that “the Xevo MRT MS is our go-to instrument for biopharmaceutical characterization.”