In a groundbreaking development, Waters Corporation has announced the expansion of its Empower Software to include data acquisition and quality control analysis from Multi-Angle Light Scattering (MALS) and differential Refractive Index (RI) instruments. This integration not only enhances the capabilities of biopharmaceutical laboratories but also simplifies regulatory compliance processes, potentially saving up to six months in software validation time. The Empower Software remains a global leader in chromatography data systems, facilitating over 80% of novel drug submissions to regulatory bodies.

Empower Software’s New Capabilities Transform Biotherapeutic Analysis

In an era of advancing pharmaceutical technologies, the launch of this new feature marks a significant milestone. Through its Wyatt Technology Portfolio, Waters Corporation now enables biopharmaceutical labs to manage critical quality attributes more effectively by incorporating MALS techniques into quality control protocols. These methods offer unparalleled insights into high molecular weight species that other detectors cannot detect, reducing the risk of errors during biotherapeutic testing.

Dr. Udit Batra, President & CEO of Waters Corporation, emphasized the company's dedication to integrating advanced analytical tools into their renowned Empower CDS ecosystem. By unifying compliant software with cutting-edge light scattering instrumentation, they provide customers with a streamlined solution for improving productivity and ensuring accurate data collection.

The DAWN, miniDAWN, and OptiLab Detectors will allow peptide and protein measurements to be completed within a single run, decreasing analysis times by 20%. This advancement provides earlier insights into the stability, safety, and efficacy of biologics, ensuring the highest standards are met for life-saving therapies.

William Wittbold, Senior Director of Operations at Pace Analytical, praised the integration, stating it would enhance service offerings as a Contract Development and Manufacturing Organization (CDMO). He highlighted the importance of detailed MALS data in understanding complex biotherapeutics, reinforcing customer confidence through reliable results.

This capability will become available for peptide and protein workflows starting in July 2025.

A Step Forward in Streamlining Biopharmaceutical Processes

From a journalist's perspective, this innovation exemplifies how technology can significantly impact the efficiency and reliability of pharmaceutical development. The integration of MALS with Empower Software not only reduces analysis time but also ensures greater accuracy in detecting high molecular weight species, which is crucial for ensuring the safety and efficacy of biologics. For readers, this advancement underscores the importance of adopting unified solutions in highly regulated industries like biopharmaceuticals, where precision and compliance are paramount. Ultimately, such developments bring us closer to delivering safer, more effective treatments to patients worldwide.