Multi-attribute monitoring with waters_connect™ peptide MAM: A formulation development case study

CASSS AT Europe 2023 -- LC-MS peptide multi-attribute monitoring (MAM) provides primary sequence critical quality attribute (CQA) data in a single assay. MAM has been applied to re-evaluate the Pembrolizumab formulation. Pembrolizumab is an IgG4 immunotherapy that binds to the PD‑1 receptor of T-cells to induce an immune response against tumor cells. Here we specifically concentrate on methionine oxidation: Pembrolizumab contains 7 methionine residues, with M34, M48 and M105 in heavy chain CDRs 1, 2 and 3, respectively.