Waters Corporation has announced that its Empower software now supports biologics data collection and quality control (QC) analysis of multi-angle light scattering (MALS) and refractive index (RI) instruments in its Wyatt Technology portfolio.
This integration expands the scope of critical quality attributes that a biopharmaceutical laboratory can manage with Empower Software. In addition, this advancement simplifies the process and digital footprint of collecting and submitting compliant data to regulatory authorities – from biologic drug development to quality control – and saves customers up to six months of software validation time.
Empower Software is the industry's most established and compliant chromatography data system (CDS) deployed globally, submitting data for more than 80% of novel medicines to regulatory authorities. The new integration enables the use of MALS techniques in quality control for biotherapeutics, improving efficiency and readiness to comply with Good Manufacturing Practices (GMP) while reducing the amount of training required for end-users in compliant environments.
The integration of the DAWN, miniDAWN and OptiLab detectors enables the measurement of more critical quality characteristics of peptides and proteins in a single pass, reducing analysis time by 20% and providing earlier insights into the stability, safety and efficacy of biologics.
