A Multi-Laboratory, Multi-Platform Analysis of the Multi-Attribute Method.

ABSTRACT: Background/Objectives: The multi-attribute method (MAM) has found diverse use in the analytical characterization of therapeutic protein products during their development and production. As the MAM matures it has the potential to enter quality control (QC) laboratories, consolidating and replacing many less informative chromatographic techniques; however, this requires an appropriate risk assessment and understanding of method capability. Methods: A validated MAM approach was used to quantify product quality attributes (PQAs) using three different mass spectrometers across two laboratories; the results were compared to conventional hydrophilic interaction chromatography-fluorescence detection (HILIC-FLD) and cation exchange chromatography-ultraviolet (CEX-UV) techniques. Re

SUBMITTER: Shipman J 

PROVIDER: S-EPMC12655225 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature