The workflow is based on LC-MS analysis of a protein trypNc digest and is capable of detecNng, idenNfying and quanNtaNng CQAs via a single assay with site specificity. This analyNcal workflow in combinaNon with the improvements in the data integrity of the LC-MS CDS, has resulted in the increase of use of this technology in regulated environments . The standardisaNon and implementaNon of MAM is an ongoing process within the pharmaceuNcal industry, it is a highly discussed topic at various conferences and working groups such as the MAM consorNum . At a technical level, MAM approach consists of three steps: 1) sample preparaNon consisNng of protein denaturaNon, reducNon, alkylaNon and enzymaNc digesNon; 2) chromatographic separaNon of the generated pepNdes usually by reversed phase chromatography and detecNon by high-resoluNon accurate mass spectrometry (HRAM-MS) in two phases. During Phase I of MAM (discovery phase), data-dependent acquisiNon (DDA) MS/MS is performed to enable confident idenNficaNon of peaks and development of a pepNde library. During Phase II of MAM (monitoring phase), full MS acquisiNon only is carried out for the monitoring of predefined product quality acributes; 3) data processing, analysis and reporNng for each of the two phases. During discovery phase, evaluaNon of sequence coverage, assessment of CQAs and pepNde workbook creaNon are performed on a reference product. During monitoring phase, a processing method is created including the pepNde workbook and targeted monitoring of predefined product acributes and new peak detecNon (NPD), as a non-targeted analysis, are performed, to invesNgate the presence of any new or modified species that are present in samples compared to reference materials at pre-defined levels.