New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study

Published

March 12, 2021

Author(s)

Catherine A. Mouchahoir, John E. Schiel, Rich Rogers, N. Alan Heckert, Benjamin 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, Hamakshi 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

Abstract

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 (UHPLC-MS) 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 pre-digested 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 lifecycles.

Citation

Journal of the American Society for Mass Spectrometry

Volume

32

Issue

4

Pub Type

Journals

Download Paper

DOI Link

Keywords

multi-attribute method, MAM Consortium, new peak detection, NISTmAb, purity testing

Citation

Mouchahoir, C. , Schiel, J. , Rogers, R. , Heckert, N. , Place, B. , Ammerman, A. , Li, X. , Robinson, T. , Schmidt, B. , Chumsae, C. , Li, X. , Manuilov, A. , Yan, B. , Staples, G. , Ren, D. , Veach, A. , Wang, D. , Yared, W. , Sosic, Z. , Wang, Y. , Zang, L. , Leone, A. , Liu, P. , Ludwig, R. , Tao, L. , Wu, W. , Cansizoglu, A. , Hanneman, A. , Adams, G. , Perdivara, I. , Walker, H. , Wilson, M. , Brandenburg, A. , DeGraan-Weber, N. , Gotta, S. , Shambaugh, J. , Alvarez, M. , Yu, X. , Cao, L. , Shao, C. , Mahan, A. , Nanda, H. , Nields, K. , Nightlinger, N. , Barysz, H. , Jahn, M. , Niu, B. , Wang, J. , Leo, G. , Sepe, N. , Liu, Y. , Patel, B. , Richardson, D. , Wang, Y. , Tizabi, D. , Borisov, O. , Lu, Y. , Maynard, E. , Gruhler, A. , Haselmann, K. , Krogh, T. , Sönksen, C. , Letarte, S. , Shen, S. , Boggio, K. , Johnson, K. , Ni, W. , Patel, H. , Ripley, D. , Rouse, J. , Zhang, Y. , Daniels, C. , Dawdy, A. , Friese, O. , Powers, T. , Sperry, J. , Woods, J. , Carlson, E. , Sen, K. , Skilton, S. , Busch, M. , Lund, A. , Stapels, M. , Guo, X. , Heidelberger, S. , Kaluarachchi, H. , McCarthy, S. , Kim, J. , Zhen, J. , Zhou, Y. , Rogstad, S. , Wang, X. , Fang, J. , Chen, W. , Yu, Y. , Hoogerheide, J. , Scott, R. and Yuan, H. (2021), New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study, Journal of the American Society for Mass Spectrometry, [online], https://doi.org/10.1021/jasms.0c00415 (Accessed November 23, 2024)