Waters Corporation Enhances Empower Software for Biologics Quality Control and Compliance

Waters Corporation Enhances Empower Software

Waters Corporation, listed on the NYSE as WAT, has made a groundbreaking announcement regarding its Empower™ Software. The integration of Multi-Angle Light Scattering (MALS) detectors with the software will significantly enhance the quality control (QC) processes within biopharmaceutical labs. This advancement not only streamlines regulatory compliance but also brings additional efficiency to the management of critical quality attributes of biotherapeutics.

Key Features of the New Integration

The new integration allows for the measurement of various quality attributes of peptides and proteins in a single analysis run. This innovation is expected to reduce total analysis time by approximately 20%. The enhanced software capabilities will help biopharmaceutical laboratories handle biologics data acquisition and quality control analysis more effectively, utilizing both MALS and differential Refractive Index (RI) instruments from the Wyatt Technology™ portfolio.

Waters Corporation reports that this integration simplifies the data acquisition and submission processes to regulatory bodies, potentially saving customers up to six months on software validation in GxP labs. Historically, validating new software systems in good practice laboratories has been a time-consuming process. However, with the new features of Empower Software, users can enjoy a more cohesive workflow.

Understanding the Benefits of MALS

One of the most advantageous aspects of the integration is the ability to detect high molecular weight species that other detectors might miss. Dr. Udit Batra, President and CEO of Waters Corporation, noted that the inclusion of MALS on the Empower Software platform minimizes risks of erroneous outcomes during quality control of biotherapeutics. The combination of reliable software with advanced light scattering instrumentation creates a unified solution aimed at enhancing productivity and accuracy within laboratories.

Improvements to QC and Compliance

In addition to providing a deeper understanding of complex biotherapeutics through detailed MALS data, the integration positions Waters Corporation as a leader in helping users ensure compliance with Good Manufacturing Practices (GMP). This is of utmost importance given the rigorous standards within the pharmaceutical industry that strive to maintain the safety and efficacy of life-saving therapies.

William Wittbold, Senior Director of Operations at Pace Analytical, a Contract Development and Manufacturing Organization (CDMO), provided his perspective, stating that implementing MALS within Empower Software will significantly enhance the service offerings to customers. Detailed MALS data is crucial for navigating the complexities of drug development and ensuring high-quality results.

Availability and Future Prospects

The capability to integrate MALS detectors with Empower Software will be accessible for workflows involving peptides and proteins starting from July 2025. As the integration unfolds, Waters Corporation is set to continue expanding its innovative solutions within the life sciences sector, serving not just biopharmaceutical laboratories but also contributing to the overall improvement of healthcare practices.

About Waters Corporation

Waters Corporation is celebrated for its long-standing commitment to innovation in analytical instruments and software for nearly 65 years. They focus on serving various sectors, including life sciences and environmental sciences, showcasing their dedication to ensuring the efficacy of medicines, safety of food, and purity of water. The firm operates in over 100 countries, employing more than 7,600 individuals pursuing excellence in scientific endeavors.

For more details and updates on this integration, you can visit Waters Corporation’s product page or follow them on LinkedIn, Twitter, and Facebook.