Biopharma ll: Multi-Attribute Method (MAM): Transforming Biopharmaceutical Characterization
The Multi-Attribute Method (MAM) has emerged as a powerful analytical approach that is transforming biopharmaceutical characterization by providing a more precise, comprehensive, and data-rich alternative to traditional quality control assays. MAM leverages high-resolution mass spectrometry to simultaneously monitor critical quality attributes (CQAs), detect product- and process-related impurities, and streamline regulatory compliance, thereby enhancing both product development and lifecycle management.
This talk will introduce MAM as an innovative workflow, highlighting its advantages over conventional assays, including increased specificity, reduced assay variability, and improved efficiency in biomanufacturing. We will discuss current industry applications, regulatory perspectives, and best practices for implementing MAM in quality control environments.
Highlighting the following best practices with Agilent’s software examples/screenshots:
- Simplified Workflows Execution
- Built-in Compliance-Ready Software
- Automated Data Handling with Back-up and Archiving
- Run Results Accessibility and Ease of Review/Approval
- Historical Results Accessibility and Visualization
- Management of Laboratory Instrument Compliance and Performance
Additionally, we will explore the future of MAM, including advancements in automation, AI-driven data analysis, and expanded applications beyond biopharmaceuticals into cell and gene therapies, novel modalities, and personalized medicine. Attendees will gain a deeper understanding of MAM’s transformative potential, practical implementation considerations, and the evolving roadmap for this technique in the next generation of biopharmaceutical analysis. Whether you are new to MAM or looking to expand its application within your organization, this session will provide valuable insights into its growing role in analytical sciences.
Presenter: Jared Auclair (Vice Provost Research Economic Development, Director of Bioinnovation, Northeastern University)
Jared R. Auclair, Ph.D. is currently the Dean College of Professional Studies and Director of Bioinnovation in the Office of the Provost at Northeastern University. As Vice Provost Research Economic Development, Dr. Auclair works to strengthen the bonds between our education and research missions by strengthening the integration of work-integrated credentialed learning and use-inspired research, co-creating with communities and partners while expanding our global mindset. As Director of Bioinnovation, Dr. Auclair works to leverage important University activities around biotechnology, bringing together experts from a wide range of disciplines and backgrounds to advance the expansion of Northeastern life sciences programs. In addition to these roles, Dr. Auclair holds a faculty appointment in the Department of Chemistry and Chemical Biology where he collaborates with academic researchers, industry and government in the area of biopharmaceutical development and analysis.
