Mass spectrometry has been widely used in the biopharmaceuNcal industry and is considered an essenNal tool in the characterizaNon of biotherapeuNc medicines . The level of informaNon obtained from MS analyNcs is criNcal in the characterizaNon of complex biotherapeuNc medicines. MS based analysis provides extensive informaNve data of protein variants and the amino acid composiNon of biotherapeuNcs . The data generated using MS techniques are included in product submissions for biologics license applicaNons provided to regulators . MS based assays however are open looked upon as non-QC friendly for a variety of reasons such as data integrity concerns relaNng to the CDS, data interpretaNon, instrument performance and the requirements for specialised analysts.