Qualification and Implementation of a Robust MAM Platform Across Multiple Laboratories

MDPI
August 24, 2026

Researchers from Novartis and Genedata demonstrated the successful qualification and deployment of a standardized Multi-Attribute Method (MAM) platform across six laboratories for biopharmaceutical process characterization.

The study shows how harmonized sample preparation, LC-MS analysis, and automated data processing can enable reproducible monitoring of critical quality attributes (CQAs) across large datasets and multiple sites.

Genedata Expressionist^® supports standardized, scalable processing of complex mass spectrometry data across laboratories. By enabling consistent data analysis and interpretation, the software helps researchers monitor product quality attributes and investigate their relationship to process conditions.

The paper demonstrates how digitalized, enterprise-scale MAM workflows can improve cross-site comparability, support Quality by Design (QbD), and enable wider implementation of mass spectrometry-based analytics in biologics development.