Waters integrates MALS detectors with Empower Software for improved biologics quality control and simplified regulatory compliance

Waters Corporation has 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.

Empower Software is a compliant-ready chromatography data system (CDS), widely adopted globally and used to submit data for more than 80% of novel drugs to regulatory authorities. 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.

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.

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