Waters Corporation Enhances Quality Control for Biologics with Empower Software Integration

Waters Corporation (NYSE: WAT), a leader in analytical technology, recently announced a significant advancement in the realm of biopharmaceutical quality control. Their Empower™ Software now supports the acquisition and analysis of biologics data using Multi-Angle Light Scattering (MALS) and Refractive Index (RI) detection within the extensive Wyatt Technology™ portfolio. With this integration, the company aims to not only enhance the quality control (QC) processes but also streamline regulatory compliance, thereby saving customers up to six months in software validation time.

Efficient Analysis for Quality Control

With the introduction of MALS techniques, biopharmaceutical labs can professionally manage a broader range of critical quality attributes associated with biologics. The new capabilities of Empower Software facilitate faster analysis times — reducing it by an impressive 20% for therapeutic peptides and proteins. This efficient process is crucial in producing safe and effective biologics while ensuring compliance with Good Manufacturing Practices (GMP).

Dr. Udit Batra, President and CEO of Waters, emphasized the company's commitment to integrating advanced analytical technologies into the Empower™ system. He stated, “The addition of MALS functionality to the Empower software highlights our aim of making high molecular species visible, which are often undetectable by other methods. By merging compliant software performance with powerful scattering analysis instruments, we aim to elevate productivity and data accuracy, ensuring rigorous quality controls for life-saving biological therapies.”

Understanding the Complexities of Biologics

The ability to measure multiple critical quality attributes in a single pass is revolutionary. With the integration of DAWN™, miniDAWN™, and OptiLab™ detectors, labs can gain insights into the stability, safety, and efficacy of biologics more effectively. As noted by William Wittbold, Senior Director of Operations at Pace Analytical, the integration of MALS data is crucial for understanding complex biotherapeutics. The reliability of Empower Software, combined with detailed MALS outputs, is expected to provide exceptional value to clients while ensuring high-quality delivery in pharmaceutical development.

Simplified Regulatory Compliance

One of the standout features of this new integration is the simplification of the process for capturing and transmitting compliant data to regulatory bodies – a necessity from drug development phases to quality evaluations. This shift effectively reduces the effort needed from end-users in regulated environments, making the software more accessible and user-friendly. With these enhancements, Waters Corporation aims to aid in quicker approvals for biologics, ultimately benefiting both manufacturers and patients relying on these therapies.

The new integration is expected to be available for peptide and protein workflows by July 2025. As Waters continues to pioneer advancements within the scientific community, industries involved in life sciences remain poised for transformational changes that optimize operational efficiency and clinical outcomes.

Conclusion

In conclusion, Waters Corporation's initiative in integrating MALS technology with Empower Software epitomizes a significant leap forward in biopharmaceutical quality control. By streamlining compliance processes and fostering advancements in analytical technology, Waters not only satisfies the demands of regulatory entities but also improves the overall efficacy of biologics, emphasizing their dedication to healthcare innovation and patient safety.

For further details about this integration and its implications for the pharmaceutical industry, visit Waters Corporation's product page or follow the company on LinkedIn, Twitter, and Facebook.