Thermo Scientific Straight through to breakthrough

Importance of the Topic

The Multi-Attribute Method (MAM) has emerged as a powerful analytical strategy in biopharmaceutical development and quality control, enabling simultaneous monitoring of multiple critical quality attributes (CQAs) in a single assay. Implementing a robust, end-to-end MAM platform strengthens product characterization, accelerates decision-making, and ensures regulatory compliance across the entire development lifecycle.

Objectives and Study Overview

This summary presents Thermo Scientific™ MAM 2.0, a comprehensive, single-vendor solution designed to integrate hardware, software, and service for holistic MAM implementation. The platform addresses the needs of research, development, and QC laboratories through standardized workflows, high-resolution mass spectrometry, and enterprise-grade data management.

Methodology

MAM 2.0 employs high-performance liquid chromatography (UHPLC) coupled with high-resolution accurate-mass (HRAM) Orbitrap detection for in-depth peptide mapping and attribute quantification. The workflow includes sample digestion, peptide separation on sub-2 µm C18 columns, full-scan MS and data-dependent MS/MS acquisition, followed by automated data processing algorithms for amino-acid confirmation and post-translational modification (PTM) identification. Compliance-ready eWorkflows guide QC analysts through each step, ensuring consistent results and traceability.

Used Instrumentation

• Vanquish™ Horizon and Flex UHPLC Systems (up to 1,500 bar, multi-channel mixing)
• Hypersil Gold™ Vanquish™ C18 UHPLC Columns
• Orbitrap Exploris™ 240 and Exploris™ MX Mass Spectrometers
• Thermo Scientific™ Chromeleon™ Chromatography Data System
• BioPharma Finder™ Software for peptide mapping and PTM analysis
• HyperBridge™ Software for global data connectivity
• MAM Workbook and eWorkflow modules

Main Results and Discussion

Performance evaluation demonstrated sub-3 ppm mass accuracy drift over multiple days/weeks, up to 240 K resolution at m/z 200, and scan speeds of 22 Hz, delivering reliable PTM quantification. UHPLC repeatability tests confirmed retention-time reproducibility and peak-area precision across long gradients. Integrated software facilitated seamless data acquisition, processing, and reporting in compliance with 21 CFR Part 11, enabling global knowledge sharing and accelerated CQA identification.

Benefits and Practical Applications

Implementing MAM 2.0 yields:

• Consolidation of multiple assays into a single LC-MS workflow
• Streamlined QC release testing with built-in eWorkflows
• Enhanced regulatory readiness through full audit trails and compliance features
• Improved laboratory efficiency and reduced analysis time
• Global data connectivity for multi-site consistency

Future Trends and Applications

Advancements in automated sample preparation, machine-learning–driven data analysis, and cloud-based collaboration are poised to further enhance MAM capabilities. Expansion to real-time PAT (Process Analytical Technology) monitoring and integration with single-cell and multi-omics platforms will broaden MAM’s impact in bioprocess optimization and personalized medicine.

Conclusion

Thermo Scientific MAM 2.0 delivers a fully integrated, compliance-ready solution for multi-attribute analysis in biopharmaceutical development and QC. By combining high-performance instrumentation, standardized eWorkflows, and enterprise data management, the platform empowers laboratories to achieve reproducible results, accelerate timelines, and maintain rigorous quality standards.

References

• No external references were provided in the source document.