Putting MAM on the Map
Developed at Amgen, Multi-Attribute Method (MAM) harnesses the power of high-resolution accurate mass (HRAM)-MS to support the journey of optimization of bioprocesses all the way to ensuring the safety of final biologic drugs. The ground-breaking approach which was developed from concept to reality mostly in the last decade to be leveraged for biopharma analytical strategy development and implementation in QC, has been endorsed by regulators and is now being adopted by medicine makers worldwide.
In this article series, we trace the journey of MAM from idea to real-world implementation, speaking with some of the scientists who played a key role in developing the approach.
Multi-Attribute Method Articles
What is the Multi-Attribute Method
The MAM Consortium
The MAM Consortium is a non-profit, industry-wide forum for the Multi-Attribute Method (MAM) and other LC/MS applications. These applications are used at pharmaceutical and biotechnology companies for product characterization, in-process control, and GMP release and stability testing. Currently, the MAM Consortium has over 300 members from pharmaceutical companies, regulatory agencies, CDMOs, and instrument/software vendors.
Multi-Attribute Method related articles
Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics.
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A View on the Importance of “Multi-Attribute Method” for Measuring Purity of Biopharmaceuticals and Improving Overall Control Strategy
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Multi-Attribute Method for Quality Control of Therapeutic Proteins. Rogstad S, Yan H, Wang X, Powers D, Brorson K, Damdinsuren B, Lee S.
Anal Chem. 2019; 91(22): 14170-14177
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Advancing Mass Spectrometry Technology in cGMP Environments. Ren D. Trends Biotechnol. 2020; 38(10): 1051-1053
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Industry events where the Multi-Attribute Method has been advocated
| Venue | Presenter | Year |
|---|---|---|
| USP | Bob Bailey | 2012 |
| Bioprocess International | Bob Bailey | 2013 |
| ASMS | Alain Balland | 2013 |
| CASSS MS | Alain Balland | 2013 |
| CASSS EU | Tony Mire-Sluis | 2014 |
| ASMS | Rich Rogers | 2014 |
| ASMS | Sabrina Benchaar | 2014 |
| CASSS MS | Lowell Brady | 2014 |
| CASSS MS | Rich Rogers | 2014 |
| Bioprocessing Summit | Catherine Eakin | 2014 |
| BIOMAN | Jette Wypych | 2014 |
| AAPS | Sabrina Benchaar | 2015 |
| CASSS MS | Da Ren | 2015 |
| Bioproduction | Jette Wypych | 2015 |
| CASSS WCBP | Rohini Deshpande | 2016 |
| CASSS CMC Strategy Europe | Jette Wypych | 2016 |
| BIOMAN | Richard Wu | 2016 |
| CASSS CMC Strategy US | Tamer Eris | 2016 |
| CASSS US | Jette Wypych | 2017 |
| PDA | Mike Abernathy | 2017 |
| AAPS | Mike Abernathy | 2017 |
| CASSS CMC Strategy Japan | Mike Abernathy/Jette Wypych | 2017 |
| IFPAC Workshop | Mike Abernathy/Jette Wypych | 2018 |
| CASSS EU AT Workshop | Jette Wypych/Patrick Swan | 2018 |
| AAPS | Nina Cauchon | 2018 |
| PEGS | Da Ren | 2018 |
| CASSS MS | Da Ren | 2018 |
| BIO | Jette Wypych | 2019 |
| ESACT | Jette Wypych | 2019 |
| ASMS | Da Ren | 2019 |
| CASSS MS | Zhongqi Zhang | 2019 |
| USP | Jette Wypych | 2020 |
| WCBP | Da Ren | 2020 |
| Bioprocess international | Ting Song | 2020 |
MAM Scientific Contributors
Learn more about the scientists who contributed to the Multi-Attribute Method project.
Jette Wypych
Jette Wypych is Executive Director in Attribute Sciences in the Process Development organization at Amgen, where she leads a department of more than 80 staff members with responsibilities in pre-clinical, clinical as well as commercial programs.
With more than 30 years of experience in biotechnology, Jette has been responsible for key discoveries in cytokine and hematopoietic research. For the past decade she has dedicated her time to aspects of process and product development. She has contributed to the development of several programs and been responsible for the analytical characterization and formulation development of pipeline molecules leading to the content in the chemistry, manufacturing and control (CMC) sections of numerous regulatory filings. She is currently actively advancing novel analytical technologies for implementation in the quality and manufacturing environment. More recently Jette developed the concept and application of the quality target product profile in process and product development at Amgen, advancing the QbD principles in product development. Her work has resulted in more than 40 publications.
Jette earned her graduate degree in chemical engineering from the Danish Technical University, Copenhagen, Denmark.
Da Ren
Da Ren currently holds the position of Scientific Director in Process Development at Amgen, where he is responsible for the strategy and execution of Multi-Attribute Method (MAM). Da joined Amgen in 2004 and held multiple roles with increasing responsibility from analytical development to cGMP release and stability testing. In 2015, he led the first in industry implementation of MAM in the cGMP environment. He has more than 20 publications and patents applications during his tenure at Amgen.
Da also actively contribute to the analytical community in the biotech industry. He was invited to present in many external conferences and served as session chair. Da is co-leading the industry-wide MAM Consortium and he is a member of the CASSS MS organizing committee.
He received his Ph.D. in Analytical Chemistry from the University of Akron in 2002.
Ting Song
Ting Song is a Senior Scientist at Amgen. Ting grew up in China and moved to the US in 2011 for studies at the University of California, Davis where she received a PhD. Ting joined Amgen in 2016 shortly thereafter. Her career at Amgen started in Research where she supported multiple early drug discovery projects including the pre-clinical study of AMG 510. She then transferred to Quality Control (QC) to work on the implementation of the Multi-Attribute Method (MAM) in Quality Control. This includes the validation of the MAM system to fit into the cGMP environment, the continuous improvement and optimization of MAM to be more QC user-friendly, designing training programs for QC, and supporting release and stability testing using MAM.
