Waters Integrates Multi-Angle Light Scattering Detectors with Empower Software for Improved Biologics Quality Control and Simplified Regulatory Compliance

Rhea-AI Summary

Waters Corporation (NYSE:WAT) has integrated Multi-Angle Light Scattering (MALS) and differential Refractive Index (RI) instruments from its Wyatt Technology Portfolio with Empower Software. This integration enables biologics data acquisition and quality control analysis, providing significant benefits: • Reduces software validation time by up to 6 months • Cuts analysis time for biotherapeutic peptides and proteins by 20% • Enhances quality control through absolute molecular weight measurements The integration includes DAWN, miniDAWN, and OptiLab Detectors and will be available in July 2025. Empower Software, used in over 80% of novel drug submissions to regulators, now offers improved efficiency and GMP readiness while reducing end-user training requirements in compliant settings.

Positive

• Reduces software validation time by up to 6 months, improving operational efficiency
• Decreases analysis time for biotherapeutic peptides and proteins by 20%
• Integration enables measurement of more critical quality attributes in a single run
• Enhances quality control by providing absolute molecular weight measurements
• Expands capabilities of Empower Software, which is already used in 80% of novel drug submissions

Negative

• None.

Insights

Life Sciences Instrumentation Expert

Waters' MALS-Empower integration enables faster biologics QC analysis with streamlined regulatory compliance, strengthening their analytical ecosystem for biopharma workflows.

Waters Corporation's integration of Multi-Angle Light Scattering (MALS) detectors with their Empower Software represents a significant advancement in biologics quality control. This technological integration elegantly addresses a critical pain point in biopharmaceutical manufacturing - the need for absolute molecular weight measurements without reference standards and detection of high molecular weight species that other techniques often miss.

The 20% reduction in analysis time delivers substantial throughput improvements for biotherapeutic workflows. More impressively, the six-month savings on software validation represents significant cost and time advantages in an industry where regulatory compliance is both mandatory and expensive. The validation process for GMP environments typically consumes substantial resources, making this efficiency gain particularly valuable.

Considering that Empower is reportedly used for 80% of novel drug submissions, this integration creates a streamlined regulatory pathway for biologics manufacturers using MALS data. The timing (July 2025 availability) aligns with increasing regulatory scrutiny around protein aggregation and higher-order structure characterization in biologics.

The integration showcases successful technology assimilation following Waters' Wyatt Technology acquisition, expanding their comprehensive analytical toolkit for the rapidly growing biologics market. By providing absolute molecular weight measurements that detect potentially dangerous aggregates, this solution directly supports patient safety while simplifying the analytical workflow for quality control laboratories.

Financial Analyst

This product enhancement strengthens Waters' competitive position in the high-value biologics testing market. With biologics representing a growing percentage of drug development pipelines, analytical technologies ensuring both quality and regulatory compliance can command premium pricing while creating sticky customer relationships.

The integration represents strategic leverage of Waters' Wyatt Technology acquisition, demonstrating tangible value creation from M&A activity. By incorporating MALS technology into their Empower ecosystem, Waters is building a more comprehensive offering that could drive incremental instrument and software sales while potentially increasing customer retention.

The efficiency benefits claimed - six months validation time savings and 20% analysis time reduction - provide clear ROI justification for pharmaceutical customers facing margin pressures and scrutinizing capital expenditures. This positions Waters favorably against competitors by offering a more complete biologics characterization solution within a single compliant software environment.

The endorsement from Pace Analytical, a Contract Development and Manufacturing Organization (CDMO), suggests potential adoption in the growing outsourced manufacturing segment. With Empower already established as the submission platform for 80% of novel drugs according to the release, this enhancement creates a more seamless regulatory pathway that could expand Waters' footprint in regulated QC environments.

However, with availability scheduled for July 2025, the revenue impact will not materialize in the near term, making this a long-term strategic enhancement rather than an immediate financial catalyst.

News Summary 

• Saves up to six months on compliant software validation in biopharmaceutical quality control.¹
• Reduces analysis time for biotherapeutic peptides and proteins by 20%.²
• Enhances quality control by providing absolute molecular weight of biologics and avoiding common errors encountered with other techniques.³

MILFORD, Mass., May 6, 2025 /PRNewswire/ -- Waters Corporation (NYSE:WAT) today announced that its Empower™ Software now supports biologics data acquisition and quality control (QC) analysis from Multi-Angle Light Scattering (MALS) and differential Refractive Index (RI) instruments in its Wyatt Technology™ Portfolio. This integration expands the scope of critical quality attributes that a biopharmaceutical laboratory can manage using Empower Software. Additionally, this advancement will simplify the process and digital footprint of acquiring and submitting compliant data to regulatory authorities – from biologics development through QC – saving customers up to six months of software validation time.

Integration supports high-volume quality control testing to ensure the safety of life-saving biologic therapies.

Empower Software is the industry's most established and compliant-ready chromatography data system (CDS), widely adopted globally and used to submit data for more than 80% of novel drugs to regulatory authorities.⁴ The new integration unlocks the ability to use MALS techniques in quality control for biotherapeutics, improving efficiency and Good Manufacturing Practices (GMP) readiness, while reducing end-user training in compliant settings.

"Today's launch of Empower for Multi-Angle Light Scattering Detectors underscores our commitment from the Wyatt acquisition to integrate advanced analytical technologies into our Empower CDS ecosystem," said Dr. Udit Batra, President & CEO, Waters Corporation. "Specifically, 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. By combining the strengths of compliant software with deep analytical light scattering instrumentation, we are providing customers with a unified solution that enhances productivity and data accuracy – ultimately supporting high-volume QC testing to ensure the safety of life-saving biologic therapies for patients."

The integration of the DAWN™, miniDAWN™, and OptiLab™ Detectors will enable the measurement of more critical quality attributes of peptides and proteins in a single run, reducing analysis time by 20% and providing earlier insights into the stability, safety, and efficacy of biologics.

"As a Contract Development and Manufacturing Organization (CDMO), we anticipate that MALS on Empower Software will enhance our service offerings," said William Wittbold, Senior Director of Operations, at Pace Analytical. "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."

The capability to integrate the DAWN, miniDAWN, and OptiLab Detectors with Empower Software will be available for peptide and protein workflows in July 2025. Learn more by visiting our product page. 

Additional Resources

     -       Learn more about the MALS integration with Empower Software.
     -       Follow and connect with Waters LinkedIn, Twitter, and Facebook.

ABOUT: Waters Corporation (NYSE:WAT) is a global leader in analytical instruments, separations technologies, and software, serving the life, materials, food, and environmental sciences for over 65 years. Our Company helps ensure the efficacy of medicines, the safety of food and the purity of water, and the quality and sustainability of products used every day. In over 100 countries, our 7,600+ passionate employees collaborate with customers in laboratories, manufacturing sites, and hospitals to accelerate the benefits of pioneering science.

Waters, Empower, DAWN, miniDAWN, OptiLab, and Wyatt Technology are trademarks of Waters Technologies Corporation.

Contact:

Molly Gluck
Head of External Communications
Waters Corporation
molly_gluck@waters.com
Mobile: +1.617.833.8166

1. In a recent survey of 50 MALS users, responding to the question "How long does it typically take you to validate new software in a GxP lab," the average time was reported as 6 months since it is one software instead of two.

2. In a recent survey of 50 MALS users, responding to the question "How much time, as a percentage of total working time, would you save on average if you could use your primary CDS software (LC software) for MALS data analysis," the average time saving was reported as 20%.

3. White paper WP1615: "SEC-MALS for absolute biophysical characterization" describes the challenges associated with determining basic physical properties of biologics in solution, and provides examples of how multi-angle light scattering can reduce the occurrence of erroneous results prevalent in relative measurement techniques. MALS provides absolute results from first principles, avoiding errors of relative measures, and is independent of retention time, reference materials, and column interactions.

4. Presented at the J.P. Morgan 43rd Annual Healthcare Conference. According to internal analysis, ~80% of the drugs filed with the FDA, EMA, and China National Medical Products Administration (NMPA) in 2023 were done so using Empower Software. Source: Waters data and estimates.

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SOURCE Waters Corporation

FAQ

What are the key benefits of Waters' MALS integration with Empower Software?

The integration reduces software validation time by up to 6 months, cuts analysis time by 20% for biotherapeutics, and enhances quality control through absolute molecular weight measurements.

When will Waters (WAT) launch the MALS integration with Empower Software?

The integration of DAWN, miniDAWN, and OptiLab Detectors with Empower Software will be available for peptide and protein workflows in July 2025.

How widely used is Waters' Empower Software in drug submissions?

Empower Software is used to submit data for more than 80% of novel drugs to regulatory authorities.

What detectors are included in Waters' MALS integration with Empower Software?

The integration includes DAWN, miniDAWN, and OptiLab Detectors from Waters' Wyatt Technology Portfolio.

How does Waters' MALS integration improve biotherapeutic analysis?

The integration reveals high molecular weight species not visible to other detectors, reducing erroneous results and providing earlier insights into stability, safety, and efficacy of biologics.