Waters Corporation Enhances Empower Software with MALS Detectors for Better Biologics QC

Waters Corporation Takes Biologics Quality Control to New Heights

Waters Corporation, a pioneer in analytical instruments, has made a significant advancement by integrating its Empower Software with Multi-Angle Light Scattering (MALS) detectors. This integration is poised to revolutionize the quality control (QC) processes within biopharmaceutical laboratories, enabling more efficient testing of biologics and simplifying compliance with regulatory standards.

Empowering Quality Control with MALS

The new functionality of Empower Software allows for seamless data acquisition from MALS and differential Refractive Index (RI) instruments from the Wyatt Technology portfolio. This represents a remarkable enhancement in managing critical quality attributes of biologics, ultimately ensuring the safety and efficacy of life-saving therapies.

One of the key benefits of this integration is its potential to save biopharmaceutical companies up to six months on compliant software validation. Traditional validation processes can be cumbersome, often leading to extended timelines for product development. The Empower Software, being widely adopted for more than 80% of novel drug submissions to health authorities globally, streamlines this process, offering unparalleled efficiency.

Improved Efficiency and Error Reduction

Empower Software is recognized for its compliance-ready capabilities, providing a trusted platform for biopharmaceutical laboratories. The integration of MALS technology significantly enhances the quality of data collected during QC testing. MALS techniques unveil high molecular weight species that are often undetectable with conventional methods, thus diminishing the risk of erroneous results.

According to Dr. Udit Batra, CEO of Waters Corporation, this integration underscores their commitment to leveraging advanced technologies in their product offerings. The alignment of MALS with Empower Software enhances both productivity and data accuracy, which is essential for high-volume QC testing in the biotherapeutics sector.

Reduced Analysis Time and Enhanced Insights

The deployment of MALS within the Empower ecosystem not only improves the accuracy of QC testing but also reduces the analysis time for biotherapeutic peptides and proteins by approximately 20%. This time reduction is critical as faster turnaround can lead to quicker decision-making in drug development. The ability to measure multiple critical quality attributes in a single run provides researchers early insights into the stability and safety of biologics.

William Wittbold, Senior Director of Operations at Pace Analytical, comments on how this integration is set to enhance their service offerings as a Contract Development and Manufacturing Organization (CDMO). The detailed data garnered from MALS will enable better understanding and characterization of complex biotherapeutics, thereby delivering superior quality results to their clients.

Looking Ahead: Availability and Impact

The integration of MALS technology with Empower Software is set to be available for peptide and protein workflows by July 2025. As the biopharmaceutical landscape continues to evolve, advancements like this integration will be pivotal in ensuring patient safety and improving therapeutic outcomes.

In summary, Waters Corporation is leading the charge in enhancing biopharmaceutical quality control with its latest software advancements. By harnessing the power of MALS technology, Waters is not only streamlining QC processes but also ensuring that biopharmaceutical products meet the highest safety standards.

As Waters continues to innovate, it remains committed to supporting the life sciences industry in ensuring the efficacious delivery of medicines that enhance the quality of life globally.

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