On May 12, 2025, Waters Corporation (NYSE: WAT), a leader in analytical instruments and software, announced a significant enhancement to its Empower™ Software. This latest update integrates Multi-Angle Light Scattering (MALS) and differential Refractive Index (RI) instruments from its Wyatt Technology™ portfolio, allowing biopharmaceutical laboratories to manage critical quality attributes more efficiently. This integration is expected to streamline data acquisition and quality control (QC) processes while simplifying regulatory compliance for the biopharmaceutical sector.

2. Streamlining Regulatory Compliance

The integration of MALS capabilities into Empower Software is particularly noteworthy as it not only enhances the analytical capabilities available to biopharmaceutical companies but also aims to reduce the digital footprint of acquiring and submitting compliant data to regulatory authorities. This advancement could potentially save customers up to six months in software validation time, a crucial factor for companies engaged in drug development.

Dr. Udit Batra, President & CEO of Waters Corporation, emphasized the importance of this integration in ensuring accurate results for biotherapeutics. "MALS supported on Empower Software reveals high molecular weight species that are not visible to other detectors – reducing the risk of erroneous results in biotherapeutic quality control," he stated. This enhancement is designed to bolster productivity and data accuracy, which are vital for ensuring the safety of life-saving biologic therapies for patients.

3. Efficiency Gains and Data Accuracy

The integration of the DAWN™, miniDAWN™, and OptiLab™ detectors into the Empower Software will enable laboratories to measure more critical quality attributes of peptides and proteins in a single run. This increased efficiency is expected to reduce analysis time by 20%, allowing for earlier insights into the stability, safety, and efficacy of biologics.

William Wittbold, Senior Director of Operations at Pace Analytical, a Contract Development and Manufacturing Organization (CDMO), expressed optimism about the new capabilities. "The detailed MALS data is essential for understanding complex biotherapeutics. Combined with the reliability of Empower Software, we believe this integration will deliver exceptional value to our customers, ensuring our drug development partners receive the highest quality results."

4. Implementation Timeline

The integration of MALS capabilities into Empower Software is set to be available for peptide and protein workflows starting July 2025. This strategic timing aligns with the ongoing demand for enhanced analytics in the biopharmaceutical sector, particularly as the industry continues to evolve and adapt to new regulatory requirements.

5. Conclusion

Waters Corporation's latest press release showcases a significant stride in the integration of advanced analytical technologies within its Empower Software, reinforcing the company's commitment to enhancing quality control in biopharmaceuticals. As the industry increasingly relies on sophisticated data analysis to ensure drug safety and efficacy, this integration not only represents a technological advancement but also a pivotal move towards simplifying regulatory compliance, ultimately benefiting both manufacturers and patients alike.

For more information about the MALS integration with Empower Software, interested parties can visit Waters Corporation's product page.

Original press release