Development, qualification, and application of a highly efficient and robust new peak detection workflow for the LC-MS peptide mapping multi-attribute method.

ABSTRACT: The multi-attribute method (MAM) by liquid chromatography-mass spectrometry peptide mapping has the potential to replace multiple conventional HPLC- and capillary electrophoresis-based purity/impurity assays for release and stability testing of protein biopharmaceuticals such as monoclonal antibodies. Prerequisite is the availability of the new peak detection (NPD) functionality to reliably detect new, absent, and changed peptide species that may impair the quality, safety, and efficacy of the drug. Here, we describe the development, qualification, and application of a highly efficient and robust NPD workflow within the Genedata Expressionist® software. The detection thresholds have been rationally designed, and the NPD workflow has been successfully validated according to ICH Q2 guideline

SUBMITTER: Pohl T 

PROVIDER: S-EPMC12520078 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature