Multi-attribute method (MAM): an emerging analytical workflow for biopharmaceutical characterization, batch release and cGMP purity testing at the peptide and intact …

S Millán-Martín, C Jakes, S Carillo… - Critical reviews in …, 2024 - Taylor & Francis
The rapid growth of biotherapeutic industry, with more and more complex molecules
entering the market, forces the need for advanced analytical platforms that can quickly and …

Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control

F Yang, J Zhang, A Buettner, E Vosika, M Sadek, Z Hao… - MAbs, 2023 - Taylor & Francis
The multi-attribute method (MAM), a liquid chromatography-mass spectrometry (LC-MS)-
based peptide mapping method, has gained increased interest and applications in the …

Recent Applications of Quantitative Mass Spectrometry in Biopharmaceutical Process Development and Manufacturing

X Li - Journal of Pharmaceutical and Biomedical Analysis, 2023 - Elsevier
Biopharmaceutical products have seen rapid growth over the past few decades and
continue to dominate the global pharmaceutical market. Aligning with the quality by design …

[HTML][HTML] Compliance and regulatory considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory

A Gervais, EHC Dirksen, T Pohl… - European Journal of …, 2023 - Elsevier
Multi-attribute methods employing mass spectrometry are applied throughout the
biopharmaceutical industry for product and process characterization purposes but are not …

Multi‐Attribute Method (MAM) Analytical Workflow for Biotherapeutic Protein Characterization from Process Development to QC

S Millán‐Martín, C Jakes, S Carillo, J Bones - Current Protocols, 2023 - Wiley Online Library
The multi‐attribute method (MAM) has emerged significantly in recent years to support
biotherapeutic protein characterization from process development to the QC environment …

Targeted CQA analytical control strategy for commercial antibody products: Replacing ion-exchange chromatography methods for charge heterogeneity with multi …

AR Evans, J Mulholland, MJ Lewis, P Hu - Mabs, 2024 - Taylor & Francis
Peptide mapping with mass spectrometry (MS) is an important tool for protein
characterization in the biopharmaceutical industry. Historically, peptide mapping monitors …

In-Depth Characterization for Methionine Oxidization in Complementary Domain Region by Hydrophobic Interaction Chromatography

L Tang, H Geng, L Zhang, X Wang, M Fei… - ACS Pharmacology & …, 2024 - ACS Publications
The oxidation of the complementarity-determining region (CDR) in monoclonal antibodies
(mAbs) is a critical quality attribute that can affect the clinical efficacy and safety of …

An improved workflow for the development of MS-compatible liquid chromatography assay purity and purification methods by using automated LC Screening …

J Manheim, AN Singh, P Aggarwal, FN Aldine… - Analytical and …, 2024 - Springer
The development of liquid chromatography UV and mass spectrometry (LC-UV–MS) assays
in pharmaceutical analysis is pivotal to improve quality control by providing critical …

[HTML][HTML] Characterization and validation of a middle-down hydrophobic interaction chromatography method to monitor methionine oxidation in IgG1

S Khalil, N Patel, F Bevillard-Kumar, C Chéry… - … of Pharmaceutical and …, 2023 - Elsevier
Post-translational modifications (PTMs) of therapeutic monoclonal antibodies (mAbs) can
impact the efficacy of a drug. Methionine oxidation can alter the overall hydrophobicity of an …