論文掲載：MAMを用いたLC-MSペプチドマッピングにおける高効率かつ堅牢な新規ピーク検出ワークフローの開発・適格性評価・応用

mAbs
October 13, 2025

Genedata Expressionist^®には、モノクローナル抗体などのバイオ医薬品の品質管理においてMAMを導入するために開発・検証された堅牢な新規ピーク検出ワークフローが組み込まれています。ICH Q2ガイドラインに基づいて設計された本ワークフローは、製品の出荷試験や安定性試験におけるMAM活用の大きな進歩を示します。

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 guidelines. Individual case studies, including stability testing of drug product and detection of unknown impurities in drug substance, highlight the workflows’ ability to reliably recognize relevant peptide species below 1% relative abundance without reporting any false positive peaks. The application of this NPD workflow signifies a substantial leap forward in the use of MAM as a quality control tool, as it allows identification of true positive peaks at adequate sensitivity in the absence of false positive peaks.