posted on 2021-03-12, 19:05authored byTrina Mouchahoir, John E. Schiel, Rich Rogers, Alan Heckert, Benjamin J. Place, Aaron Ammerman, Xiaoxiao Li, Tom Robinson, Brian 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 Ludwig, Li Tao, Wei Wu, Ahmet Cansizoglu, Andrew 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 Shao, Andrew Mahan, Hirsh Nanda, Kristen Nields, Nancy Nightlinger, Helena Maria Barysz, Michael Jahn, Ben Niu, Jihong Wang, Gabriella Leo, Nunzio Sepe, Yan-Hui Liu, Bhumit A. Patel, Douglas Richardson, Yi Wang, Daniela Tizabi, Oleg V. Borisov, Yali Lu, Ernest L. Maynard, Albrecht Gruhler, Kim F. Haselmann, Thomas N. Krogh, Carsten P. Sönksen, Simon Letarte, Sean Shen, Kristin Boggio, Keith Johnson, Wenqin Ni, Himakshi Patel, David Ripley, Jason C. Rouse, Ying Zhang, Carly Daniels, Andrew Dawdy, Olga Friese, Thomas W. Powers, Justin B. Sperry, Josh Woods, Eric Carlson, K. Ilker Sen, St John Skilton, Michelle Busch, Anders Lund, Martha Stapels, Xu Guo, Sibylle Heidelberger, Harini Kaluarachchi, Sean McCarthy, John Kim, Jing Zhen, Ying Zhou, Sarah Rogstad, Xiaoshi Wang, Jing Fang, Weibin Chen, Ying Qing Yu, John G. Hoogerheide, Rebecca Scott, Hua Yuan
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.