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 …, 2023 - 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 …

High concentration formulation developability approaches and considerations

J Zarzar, T Khan, M Bhagawati, B Weiche… - MAbs, 2023 - Taylor & Francis
The growing need for biologics to be administered subcutaneously and ocularly, coupled
with certain indications requiring high doses, has resulted in an increase in drug substance …

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 …

[HTML][HTML] 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 …

Technical considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory

T Pohl, A Gervais, EHC Dirksen, V D'Alessio… - 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 …

[HTML][HTML] Leveraging rAAV bioprocess understanding and next generation bioanalytics development

JM Escandell, DA Pais, SB Carvalho, K Vincent… - Current Opinion in …, 2022 - Elsevier
Highlights•Highlight CMC strategies to address the increasing rAAV vector demand.•Outline
solutions in the areas of cell line development and upstream processing to increase AAV …

Improvements on sample preparation and peptide separation for reduced peptide mapping based multi-attribute method analysis of therapeutic monoclonal …

X Li, B Rawal, S Rivera, S Letarte… - … of Chromatography A, 2022 - Elsevier
The mass spectrometry based multi-attribute method (MAM) has gained popularity in the
field of biopharmaceutical analysis as it promises a single method for comprehensive …

Development and optimization of a LC-MS based multi-attribute method (MAM) workflow for characterization of therapeutic Fc-fusion protein

A Puranik, P Rasam, P Dandekar, R Jain - Analytical Biochemistry, 2023 - Elsevier
The growing complexity of novel biopharmaceutical formats, such as Fc-fusion proteins, in
increasingly competitive environment has highlighted the need of high-throughput analytical …

Analytical performance evaluation of identity, quality-attribute monitoring and new peak detection in a platform multi-attribute method using Lys-C digestion for …

X Li, NA Pierson, X Hua, BA Patel, MH Olma… - Journal of …, 2023 - Elsevier
The use of multi-attribute method (MAM) for identity and purity testing of biopharmaceuticals
offers the ability to complement and replace multiple conventional analytical technologies …

Single-Use Biosensors for Biomanufacturing: Perspective on the State-of-the-Art

Z Hetzler, N Lott, AD Poonam, S Dalgan… - Current Opinion in …, 2023 - Elsevier
The biomanufacturing industry has experienced significant transformations in the past 10
years, driven by changing industry trends and rapidly maturing new technologies. However …