Waters Corporation Enhances Biologics Quality Control with Empower Software Integration

Waters Corporation Revolutionizes Biologics Quality Control with Empower Software

In the ever-evolving landscape of biopharmaceuticals, ensuring the quality and safety of biologics is paramount. Recently, Waters Corporation announced a significant upgrade to their Empower™ Software, specifically designed for data acquisition and quality control (QC) analysis of biologics. This enhancement involves the integration of Multi-Angle Light Scattering (MALS) detectors and differential Refractive Index (RI) instruments from their Wyatt Technology™ Portfolio.

This integration aims to streamline the quality control process of biopharmaceuticals while simplifying compliance with regulatory requirements. With this new setup, labs can experience up to six months of time savings in software validation processes, a remarkable advancement in an industry where time is often of the essence. Moreover, the time taken to analyze biotherapeutic peptides and proteins can expect a reduction of about 20%, making it a game-changer for biopharmaceutical quality control.

What does this mean for laboratories operating in the demanding field of biologics? The incorporation of MALS technology enables them to measure critical quality attributes with greater precision and avoid common pitfalls associated with other measurement techniques. According to Dr. Udit Batra, President and CEO of Waters Corporation, this move underscores the company's commitment to integrating advanced analytical technologies into their Empower CDS ecosystem. By offering insights into high molecular weight species that other detectors might miss, the MALS integration significantly mitigates the risk of erroneous results in biotherapy quality control.

Enhancing Efficiency and Reliability

One of the compelling advantages of using the integrated MALS detectors—DAWN™, miniDAWN™, and OptiLab™—is the ability to perform multiple measurements in one analytical run. This not only conserves valuable time but also allows for the early detection of stability, safety, and efficacy concerns related to biological products. The results from these analyses provide a comprehensive understanding crucial for the development and commercialization of biotherapeutics, all while adapting to Good Manufacturing Practices (GMP).

William Wittbold, Senior Director of Operations at Pace Analytical, highlighted the significance of this integration. As a Contract Development and Manufacturing Organization (CDMO), Pace Analytical anticipates that MALS technology in Empower Software will significantly improve their service offerings. Detailed MALS data are vital for the characterization of complex biologics, and when paired with the reliability of Empower Software, this leap in technology promises exceptional value for clients, ensuring that drug development partners receive the highest quality outcomes.

Future Prospects

The integration feature will be operational for peptide and protein workflows beginning in July 2025. This development marks an exciting era for the biopharma sector, where the balance between quality and regulatory adherence can often be a challenging act. Through advanced integration and innovative technology, Waters Corporation aims to provide lab managers and scientists with tools that not only simplify regulatory compliance but also enhance the overall efficiency of quality assurance processes.

As the industry shifts towards more sophisticated analytical techniques, it is evident that tools like Waters’ Empower Software will play a crucial role in shaping the future of quality control in biopharmaceutical development. For those keen on learning more about the integration and how it aligns with state-of-the-art practices in quality assurance, further resources are available on their product page. Additionally, Waters encourages professionals to connect via their social media channels on LinkedIn, Twitter, and Facebook.

Waters Corporation, a global leader in analytical instrumentation and software with over 65 years of expertise, continuously strives to advance the efficacy of medications, food safety, and overall environmental quality. With a dedicated workforce across numerous countries, Waters collaborates closely with its clients—ranging from labs to hospitals—to deliver pioneering scientific benefits.