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 …

Comprehensive multi-attribute method workflow for biotherapeutic characterization and current good manufacturing practices testing

S Millán-Martín, C Jakes, S Carillo, R Rogers, D Ren… - Nature …, 2023 - nature.com
The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS)-
based method that is used to directly characterize and monitor numerous product quality …

Analytical similarity assessment of biosimilars: global regulatory landscape, recent studies and major advancements in orthogonal platforms

N Nupur, S Joshi, D Gulliarme… - … in Bioengineering and …, 2022 - frontiersin.org
Biopharmaceuticals are one of the fastest-growing sectors in the biotechnology industry.
Within the umbrella of biopharmaceuticals, the biosimilar segment is expanding with …

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 map** method, has gained increased interest and applications in the …

Collision cross-section calibration strategy for lipid measurements in SLIM-based high-resolution ion mobility

BS Rose, JC May, AR Reardon… - Journal of the American …, 2022 - ACS Publications
Structures for lossless ion manipulation-based high-resolution ion mobility (HRIM) interfaced
with mass spectrometry has emerged as a powerful tool for the separation and analysis of …

[HTML][HTML] Intact multi-attribute method (iMAM): A flexible tool for the analysis of monoclonal antibodies

S Carillo, A Criscuolo, F Füssl, K Cook… - European Journal of …, 2022 - Elsevier
The availability of rapid methods that can accurately define and quantify biopharmaceutical
critical quality attributes has been the driving force for the implementation of mass …

Interlaboratory evaluation of a user-friendly benchtop mass spectrometer for multiple-attribute monitoring studies of a monoclonal antibody

CI Butré, V D'atri, H Diemer, O Colas, E Wagner… - Molecules, 2023 - mdpi.com
In the quest to market increasingly safer and more potent biotherapeutic proteins, the
concept of the multi-attribute method (MAM) has emerged from biopharmaceutical …

ID–MAM: a validated identity and multi-attribute monitoring method for commercial release and stability testing of a bispecific antibody

AR Evans, AS Hebert, J Mulholland… - Analytical …, 2021 - ACS Publications
Post-translational modifications (PTMs) that impact the safety or efficacy of protein
therapeutics are critical quality attributes (CQAs) that need to be controlled to ensure product …

A robust purity method for biotherapeutics using new peak detection in an LC–MS-based multi-attribute method

M Sadek, BN Moore, C Yu, N Ruppe… - Journal of the …, 2023 - ACS Publications
New peak detection (NPD), as part of the LC–MS-based multi-attribute method (MAM),
allows for sensitive and unbiased detection of new or changing site-specific attributes …

A native multi-dimensional monitoring workflow for at-line characterization of mAb titer, size, charge, and glycoform heterogeneities in cell culture supernatant

S Bhattacharya, S Joshi, AS Rathore - Journal of Chromatography A, 2023 - Elsevier
With growing maturity of the biopharmaceutical industry, new modalities entering the
therapeutic design space and increasing complexity of formulations such as combination …