New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study

作者：Trina Mouchahoir, John E. Schiel, Rich Rogers, N. Alan Heckert, Benjamin J. Place, Aaron Ammerman, Xiaoxiao Li, Tom Robinson, Brian D. Schmidt, Chris M. Chumsae, Xinbi Li, Anton V. Manuilov, Bo Yan, Gregory O. Staples, Da Ren, Alexander J. Veach, Dongdong Wang, Wael Yared, Zoran Sosic, Yan Wang, Li Zang, Anthony M. Leone, Peiran Liu, Richard T. Ludwig, Li Tao, Wei Wu, Ahmet Cansizoglu, Andrew J. S. Hanneman, Greg W. Adams, Irina Perdivara, Hunter Walker, Margo Wilson, Arnd Brandenburg, Nick DeGraan-Weber, Stefano Gotta, Joe Shambaugh, Melissa Alvarez, X. Christopher Yu, Li Cao, Chun Ming Shao, Andrew D. Mahan, Hirsh Nanda, Kristen Nields, Nancy S. Nightlinger, Helena Maria Barysz, Michael K. Jahn, Ben Niu, Jihong Wang, G. Leo, Nunzio Sepe, Yan-Hui Liu, Bhumit A. Patel, Douglas D. Richardson, Yi Nuo Wang, Daniela Tizabi, Oleg Borisov, Yali Lu, Ernest L. Maynard, Albrecht Gruhler, Kim F. Haselmann, Thomas Nylandsted Krogh, Carsten P. Sönksen, Simon Letarte, Sean Shen, Kristin Boggio, Keith Johnson, Wenqin Ni, Himakshi K. Patel, David Ripley, Jason C. Rouse, Ying Zhang, Carly Daniels, Andrew Dawdy, Olga V. Friese, Thomas W. Powers, Justin B. Sperry, Josh Woods, Eric D. Carlson, K. Ilker Sen, St John Skilton, Michelle Busch, Anders L. Lund, Martha D. Stapels, Xu Guo, Sibylle Heidelberger, Harini Kaluarachchi, Sean M. McCarthy, John Kim, Jing Zhen, Ying Yin Zhou, Sarah Rogstad, Xiaoshi Wang, Jing Fang, Weibin Chen, Ying Qing Yu, John G. Hoogerheide, Rebecca A. Scott, Hua Yuan · 发表于：Journal of the American Society for Mass Spectrometry · 年份：2021 · DOI：10.1021/jasms.0c00415 · 被引用次数：44 · 研究领域：Protein purification and stability、Pesticide Residue Analysis and Safety、Advanced Proteomics Techniques and Applications

The Multi-Attribute Method (MAM) Consortium was initially formed as a venue to harmonize best practices, share experiences, and generate innovative methodologies to facilitate widespread integration of the MAM platform, which is an emerging ultra-high-performance liquid chromatography-mass spectrometry application. Successful implementation of MAM as a purity-indicating assay requires new peak detection (NPD) of potential process- and/or product-related impurities. The NPD interlaboratory study described herein was carried out by the MAM Consortium to report on the industry-wide performance of NPD using predigested samples of the NISTmAb Reference Material 8671. Results from 28 participating laboratories show that the NPD parameters being utilized across the industry are representative of high-resolution MS performance capabilities. Certain elements of NPD, including common sources of variability in the number of new peaks detected, that are critical to the performance of the purity function of MAM were identified in this study and are reported here as a means to further refine the methodology and accelerate adoption into manufacturer-specific protein therapeutic product life cycles.