Waters Integrates Advanced Technology for Enhanced Quality Control
Waters Corporation is proud to announce a significant advancement in its Empower Software, designed to streamline biologics quality control. This integration allows the software to support data acquisition and quality control analysis from Multi-Angle Light Scattering (MALS) and differential Refractive Index (RI) instruments, enhancing its Wyatt Technology Portfolio. With this integration, biopharmaceutical laboratories can manage essential quality attributes more effectively while simplifying compliance with regulatory standards.
Significant Time Savings
The integration of MALS with Empower Software is particularly noteworthy as it can save users up to six months on software validation processes. This time-saving aspect is crucial in the biopharmaceutical industry, where compliance and timely data submission are of utmost importance. Moreover, users have reported a 20% reduction in analysis time for biotherapeutic peptides and proteins, which bolsters overall efficiency.
Improving Data Accuracy and Quality Control
The Empower Software is already a well-established chromatography data system (CDS), recognized for its capability to facilitate compliance-ready submissions for more than 80% of novel drugs to regulatory authorities. The new integration enhances the software’s analytical capabilities, allowing for more thorough quality control processes. Notably, MALS techniques will reveal high molecular weight species that may escape detection with traditional methods, thus reducing the potential for errors in quality assessment.
User Perspectives on Integration
Industry leaders recognize the value of this integration. For example, William Wittbold, Senior Director of Operations at Pace Analytical, emphasized that the detailed MALS data provided by Empower Software is crucial for understanding complex biotherapeutics. The confidence that comes with this integration allows them to assure their drug development partners of high-quality results.
Transforming Regulatory Submission Processes
This integration introduces new efficiencies from biologics development through quality control, simplifying how laboratories acquire and submit compliant data. This efficient digital footprint addresses the growing need to minimize time and resources spent on regulatory compliance.
Enhanced Analytical Capabilities
The integration includes the DAWN™, miniDAWN™, and OptiLab™ Detectors, enabling the assessment of critical quality attributes of peptides and proteins within a single analytical run. This not only speeds up the analysis but also leads to earlier insights regarding the stability and efficacy of biologics. Such advancements can make a substantial difference in the fast-paced world of drug development and manufacturing.
Adapting to Market Needs
With the capability to leverage MALS on Empower Software now integrated, Waters Corporation is set to enhance the strategic service offerings as a Contract Development and Manufacturing Organization (CDMO). This integration meets the significant demand for improved data reliability and accuracy in the biologics market.
Stay Connected with Waters Corporation
As the launch date for the MALS integration approaches, Waters Corporation invites interested customers to learn more about the developments on their website. They continue to push the boundaries of analytical technologies, ensuring they provide reliable solutions that can adapt to the ever-evolving landscape of biopharmaceutical requirements.
Frequently Asked Questions
What is the main feature of the Empower Software integration?
The Empower Software now supports data acquisition and quality control analysis from Multi-Angle Light Scattering (MALS) and differential Refractive Index (RI) instruments, enhancing its functionality for biopharmaceutical applications.
How does MALS integration benefit users?
The MALS integration reduces analysis time for biotherapeutic peptides and proteins by 20% and streamlines compliance processes, potentially saving users up to six months on software validation.
What impact does this have on quality control?
This integration improves data accuracy by identifying high molecular weight species that traditional detectors might miss, minimizing the risk of erroneous results in quality control assessments.
Who benefits from this software enhancement?
Biopharmaceutical laboratories, Contract Development and Manufacturing Organizations (CDMOs), and companies involved in drug development will benefit from enhanced efficiency and data reliability.
When will the integration capabilities be available?
The capability to integrate MALS with Empower Software for peptide and protein workflows is expected to be available in July 2025.
