Waters Unveils Groundbreaking Xevo Charge Detection Mass Spectrometry for Biotherapeutics

Waters Corporation, a global leader in analytical instruments, has launched its latest innovation, the Xevo Charge Detection Mass Spectrometer (CDMS), which promises to transform the landscape of biotherapeutic development. As the pharmaceutical industry increasingly pivots to advanced therapies, including cell and gene therapy, Waters' new technology arrives at a pivotal moment, addressing existing challenges in analyzing mega-mass biomolecules like never before.

The Xevo CDMS stands out for its capability to facilitate direct and accurate mass detection of the largest and most heterogeneous biomolecules critical to the development of next-generation therapeutics. Traditional methods often fall short in resolving complex biomolecular structures; however, the new system boasts the ability to perform individual-particle mass measurement on molecules exceeding 150 MDa. This enhancement is especially pertinent as myriad drug modalities continue to evolve, compelling scientists to seek out tools that can keep pace.

Significant Advancements in Biomolecule Analysis

One of the standout features of the Xevo CDMS is its precision in distinguishing between various states of viral vector capsids—namely empty, partial, and full—within ten minutes and using 100-fold less sample volume than traditional approaches. This efficiency not only accelerates analysis times but also opens the gateway to real-time characterization of gene therapies during crucial stages of process development. The system is designed to operate effectively even with sample concentrations as low as 10^10 vp/mL, a significant improvement over previous techniques.

Dr. Udit Batra, President and CEO of Waters Corporation, expressed the company's commitment to innovation, stating, "We continue to make investments in large molecules, recognizing that advanced tools for bioanalytical characterization play a critical role in driving therapeutic breakthroughs. Today, we are proud to introduce the first-of-its-kind Xevo Charge Detection Mass Spectrometer, enabling the precise analysis of previously unmeasurable molecules."

Indeed, for companies engaged in developing gene therapies, the ramifications of the Xevo CDMS are substantial. Timothy Fenn, Ph.D., Vice President of Analytical Development and Quality Control at Lexeo Therapeutics, emphasized the game-changing nature of CDMS, stating, "With CDMS, we're asking questions we didn't know we could ask. It's a game-changer for our analytical workflows, enabling us to generate accurate, reproducible results in minutes."

How Does It Work?

At the technology's core lies the Electrostatic Linear Ion Trap (ELIT), a groundbreaking innovation that allows for direct measurement of individual ions through simultaneous analysis of their mass-to-charge ratio and mass. This pioneering approach was developed through collaborative research at Indiana University, involving eminent professors in the field. Waters Corporation acquired the associated technology and intellectual property in 2022, expediting its commercialization path.

In real-world applications, the Xevo CDMS system is supported by GxP-ready waters_connect™ Software Interface, ensuring that users can effectively navigate their analytical processes. The simplification brought about by the CDMS negates the need for complex deconvolution or digestion techniques often required to analyze intricate biomolecular structures.

As biotherapeutic researchers seek to enhance the safety and efficacy of their products, the Xevo CDMS significantly reduces workflow bottlenecks common in traditional methods. This technology is poised to play a critical role in informing regulatory approval processes and assisting manufacturers in meeting evolving industry standards.

From discovery and research to process development and manufacturing, the Waters Xevo CDMS stands ready to support a broad spectrum of applications vital for propelling the life sciences forward.

Waters Corporation continues its legacy as a trusted partner in scientific innovation, dedicated to ensuring the quality and efficacy of therapies that influence countless lives. The future of biotherapeutic development is here, marked by enhanced precision, efficiency, and a more thorough understanding of the diverse landscape of biomolecules.

For more information about the Xevo Charge Detection Mass Spectrometer and its capabilities, visit the Waters Corporation website or contact their team directly to explore how this technology can elevate your analytical processes.