ArticlemAbs2025
Development, qualification, and application of a highly efficient and robust new peak detection workflow for the LC-MS peptide mapping multi-attribute method.
Article in mAbs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed.
- Development and Integrated Application of the Multi-Attribute Method (MAM) in Quality Control of Biotechnological Drugs.Biotechnology and bioengineering · 2026Review
- Protein Therapeutic Quality Control Using Multi-Attribute Method (MAM): Challenges and Current Practice in cGMP Environments.Pharmaceuticals (Basel, Switzerland) · 2026Review
- System Performance Check (SPC): A Readiness Companion to Multi-Attribute Method (MAM) Analysis in Biopharmaceutical Quality Control.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Artificial Oxidation: A Major Challenge in Implementing Multi-Attribute Methods for Therapeutic Protein Analysis.Pharmaceuticals (Basel, Switzerland) · 2026Article
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
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 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.