Biopharmaceutical Characterization Complexities: A Dive into Multi-Attribute Method (MAM)

In the fast-changing landscape of biopharmaceuticals, a recent co-authored paper titled “Multi-Attribute Method (MAM): An Emerging Analytical Workflow for Biopharmaceutical Characterization, Batch Release, and cGMP Purity Testing“ discusses the status of MAM providing in-depth knowledge for industry professionals.

In this open-access paper published by the National Institute for Bioprocessing Research and Training and Thermo Fisher Scientific, the need to know about recent advancements in the field of MAM can be found.

Holistic MAM Workflow: The paper details a comprehensive MAM workflow designed for the thorough characterization of biotherapeutics. This methodology, aligned with current Good Manufacturing Practices (cGMP), provides a nuanced understanding of the intricacies involved in the production of biopharmaceuticals.

Advanced Trypsin Digestion Method: Global researchers introduce an improved trypsin digestion method. This innovation aims to minimize digestion-induced modifications on proteins, ensuring the structural integrity of therapeutic proteins.

LC-MS Monitoring: The paper explores a liquid chromatography-mass spectrometry (LC-MS) method for simultaneous monitoring of oxidation, deamidation, isomerization, and glycosylation of monoclonal antibodies. This method transforms the landscape of protein modification identification and quantification.

Dalton-Based MAM Innovation: A quadrupole Dalton-based MAM is presented, offering an approach for product characterization, process development, and quality control of therapeutic proteins. This innovation is geared up to redefine the efficiency and precision of monitoring critical quality attributes.

Sequence Variant Detection Mastery: The methodologies disclosed in the paper address the persistent challenge of detecting low-level sequence variants in recombinant monoclonal antibodies. This has significant implications for enhancing the reliability of biopharmaceutical development.

Access the Full Paper Here (Open Access): Multi-Attribute Method (MAM): An Emerging Analytical Workflow for Biopharmaceutical Characterization, Batch Release and cGMP Purity Testing at the Peptide and Intact Protein Level