peptide-log The Multi-Attribute Method (MAM) is a powerful analytical technique that leverages peptide mapping to comprehensively assess biopharmaceutical products. Utilizing liquid chromatography-mass spectrometry (LC-MS), MAM allows for the simultaneous identification, quantification, and monitoring of multiple critical quality attributes (CQAs) within a single assay, offering a streamlined and efficient approach to biopharmaceutical quality control2017年11月30日—The LC-MSpeptide MAMworkflow maximises efficiencies by combining the analysis of many PQAs into one assay. Similar to mass spectrometry based .... This peptide mapping-based method is increasingly recognized for its ability to provide in-depth characterization of biotherapeutics2023年1月16日—MAM is a peptide mapping-based methodthat takes advantage of high-resolution mass spectrometric data..
At its core, the Multi-Attribute Method (MAM) involves the enzymatic digestion of a protein into smaller peptide fragments. These peptides are then separated using liquid chromatography and analyzed by high-resolution mass spectrometry. This process generates rich datasets that can reveal a variety of attributes, such as modifications (e.g., oxidation, deamidation), sequence variants, and aggregation. The "multi-attribute" aspect refers to the method's capability to monitor numerous CQAs simultaneously at the peptide level, providing a holistic view of the product's integrity.
Peptide mapping is the foundational element of MAM. By breaking down a large protein into a unique set of peptides, it creates a "fingerprint" of the protein. This fingerprint can then be analyzed to detect subtle changes or variations that might indicate issues with product quality, stability, or manufacturing consistency. The enzymatic digestion, often using enzymes like trypsin, is a critical step that ensures reproducible fragmentation. Subsequent LC-MS analysis then resolves and identifies these peptides, allowing for the detection and quantification of modifications or other attributes.
Liquid chromatography-mass spectrometry (LC-MS) is the indispensable technology behind MAM. The liquid chromatography component separates the complex mixture of peptides generated from the enzymatic digest, while the mass spectrometer provides highly accurate mass measurements for each peptide. This combination allows for the identification of peptides based on their mass-to-charge ratio and retention time.A Streamlined Compliant Ready Workflow for Peptide- ... High-resolution mass spectrometry, in particular, is crucial for distinguishing between peptides that may have very similar masses, thereby enhancing the accuracy and sensitivity of the analysis作者：S Millán-Martín·2023·被引用次数：9—MAM is a liquid chromatography mass spectrometry (LC-MS) based peptide mapping approach, which combines the benefits from liquid chromatography coupled to high .... This LC-MS-based peptide mapping technique is central to the method's success.
The Multi-Attribute Method (MAM) offers significant advantages for biopharmaceutical development and quality control. Its ability to assess multiple attributes in a single run reduces the need for multiple, separate analytical methods, saving time and resourcesMass spectrometry-based multi-attribute method in protein .... This makes it particularly valuable for monitoring the CQAs of biotherapeutics throughout their lifecycle, from process development to commercial release and stability testingPeptidemaps were generated for innovator and three biosimilar infliximab products with the Xevo G3 QTof MS using a DIA based methodology that produced greater ....
MAM is designed to target and quantify multiple product quality attributes. These CQAs are specific characteristics that influence the safety and efficacy of biopharmaceutical products. By analyzing peptide digests, MAM can detect and quantify modifications like oxidation and deamidation, which can impact a drug's performance and stability.2017年11月30日—The LC-MSpeptide MAMworkflow maximises efficiencies by combining the analysis of many PQAs into one assay. Similar to mass spectrometry based ... It can also be used to identify and characterize sequence variants or other process-related impurities.
The adoption of MAM as a quality control (QC) tool is growing.This study evaluates the use of RapiZyme Trypsin in a MAM workflowapplied to thermally stressed infliximab innovator and three approved biosimilars. The method provides a more comprehensive and efficient alternative to traditional, often orthogonal, analytical techniques.Multi‐Attribute Method (MAM) Analytical Workflow for ... Workflows incorporating MAM aim to be streamlined and compliant-ready, facilitating its implementation in regulated environments2017年11月30日—The LC-MSpeptide MAMworkflow maximises efficiencies by combining the analysis of many PQAs into one assay. Similar to mass spectrometry based .... Organizations like the MAM Consortium are dedicated to advancing MAM and other LC/MS applications, fostering collaboration and standardization within the industry.
Characterizing biosimilars is another key application area for MAM. By comparing the peptide maps of a biosimilar to its reference product, researchers can assess similarity in terms of critical quality attributes. Studies have demonstrated the use of MAM for characterizing innovator and biosimilar products, providing detailed data on product quality and consistency. This MS-based peptide mapping method is instrumental in demonstrating the comparability of biosimilarsMAM Consortiumis an industry-wide, nonprofit 501(c)(6) organization with the mission to advance Multi-Attribute Method (MAM) and other LC/MS applications..
The field of MAM is continuously evolving, with ongoing research focused on improving workflows, increasing throughput, and expanding its applicabilityProtein Identification by MALDI-TOF-MS Peptide Mapping. Developments include automated MAM workflows, the use of advanced software for data analysis, and the exploration of MAM at different levels, such as subunit analysis. The technology is poised to play an even more significant role in the future of biopharmaceutical analysis and manufacturing.
Efforts are underway to optimize MAM workflows for greater efficiency and robustness. This includes reducing the number of missed cleavages during enzymatic digestion, which leads to more reliable data interpretation. Automation of MAM processes is also a key area of development, enabling higher sample throughput and reducing manual laborFull article: Multi-Attribute Method (MAM): An Emerging .... The integration of specialized software solutions further enhances the capabilities of MAM by enabling targeted quantification of multiple attributes within a single assay作者：AS Rathore·2024·被引用次数：8—The term "multi-attribute method" orMAMwas introduced as an LC-MS/MS-basedpeptidemapping method for in-depth monitoring of CQAs of biotherapeutics and ever ....
Beyond its established applications, MAM is being explored for new uses in biopharmaceutical analysis. Research continues to refine the technique, exploring its potential for characterizing complex biologics, detecting novel modifications, and improving the sensitivity of impurity profiling. The adaptability of MAM, particularly its ability to be applied at the peptide level, ensures its continued relevance as analytical demands increase.
In conclusion, the Multi-Attribute Method (MAM), underpinned by LC-MS and peptide mapping, represents a significant advancement in biopharmaceutical analysis作者：S Millán-Martín·2023·被引用次数：9—MAM is a liquid chromatography mass spectrometry (LC-MS) based peptide mapping approach, which combines the benefits from liquid chromatography coupled to high .... Its capacity for simultaneous, in-depth monitoring of critical quality attributes offers unprecedented efficiency and insight, making it an indispensable tool for ensuring the quality, safety, and efficacy of modern biotherapeuticsPeptidemaps were generated for innovator and three biosimilar infliximab products with the Xevo G3 QTof MS using a DIA based methodology that produced greater ....
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