The Multi-Attribute Method (MAM) for structural confirmation of protein therapeutics involves a targeted search of peptide mapping data using advanced, GMP compliance-ready software, for pre-determined components that are indicative for numerous critical quality attributes (CQA). Protein sample preparation for MAM demands reproducible, fast, and low artifact inducing proteolytic digestion into peptides; automatable methods are favored. Peptide separations must be rapid, consistent, and free of artifacts induced through detection techniques involving intense, broad spectrum UV light.
MAM enables highly accurate relative quantification (% difference) of post-translational and process induced modifications by comparison to a reference sample. High resolution accurate mass (HRAM) mass spectrometry (MS) delivers both the required sensitivity and specificity for increased confidence in the detection and quantification of post-translational modifications. Moreover, HRAM MS also brings the capability to detect additional components in parallel; this critical additional data processing capability, called ‘new peak detection’, automatically detects and flags new chromatographic components in a sample once compared to a reference. This allows MAM to deliver both quantification of known differences, and the capability to flag new unknown impurities present above pre-set detection limits.
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Resolution Matters – From Research to QC
Low resolution MS techniques have lower specificity and are unable to determine some critical modifications, especially where there are no chromatographic differences in modified and unmodified peptides. Take the example below; for co-eluting modified and wildtype peptides, high resolution accurate mass spectrometry is often required to provide the necessary selectivity to avoid erroneous results or missed modifications. The robustness of modern HRAM MS bench-top systems, combined with simple and familiar compliance-ready chromatography data system software, and the ability to monitor multiple CQAs in a single analysis, makes MAM both highly practical and desirable for GMP lab use.
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Want to Find Out More? 5 Ways How to Become A MAM Master
1. Join our European MAM Symposia 21-23 May 2019
Attend one of our European events to connect with industry experts in the Multi-Attribute Method from Symphogen; NIBRT; Sanofi; UCB; Novo Nordisk; and Thermo Fisher Scientific. Network with MAM users, and learn innovations in the workflow. Registration is free and lunch is provided, but space is limited, so register early to avoid disappointment. Register now > See agenda >
2. Read this AAPS PharmSci360 2018 Poster
Detection and Identification of New Protein Features using Multi-Attribute Monitoring (MAM) as Part of Mass Spectrometry-based Quality Control (QC) Download poster >
Hear from experts in biopharmaceutical characterization. Including Richard Rogers of Just Biotherapeutics, who gave birth to the concept of MAM, who states: “the only instrument able to consistently detect these new peaks is the Orbitrap, a high-resolving-power mass analyzer made by Thermo Fisher Scientific.” - Dr. Richard Rogers Read article >
5. Visit this website
Keep up to date with current and future technology innovations by booking this webpage: thermofisher.com/MAM