In late January, I traveled to WCBP (Well Characterized Biological Products), an industry conference that is hosted every year by the CASSS organization. It serves as a forum that brings together biopharmaceutical industry professionals and… Read more >
There are two primary multi-attribute monitoring (MAM) assay choices for biologic development and QC: subunit protein mass analysis and peptide mapping by LC-MS. Here we explore how peptide mapping LC-MS MAM workflows are being used.
Two MAM approaches for biotherapeutic analysis are being implemented today; one focused on the analysis of monoclonal antibody (mAb) subunits, and the other focused on the analysis of peptides from a protein digest (peptide mapping workflow). Both have their advantages and disadvantages. Here, we explore MAM for mAb subunit analysis.
The improvements in LC-MS technology under GxP compliant-ready informatics for biopharmaceutical analysis has prepared the industry to expand the role of MS technologies beyond product characterization toward monitoring product and process quality attributes.