| Literature DB >> 33710905 |
Trina Mouchahoir1,2, John E Schiel1,2, Rich Rogers3, Alan Heckert1, Benjamin J Place1, Aaron Ammerman4, Xiaoxiao Li4, Tom Robinson4, Brian Schmidt4, Chris M Chumsae5, Xinbi Li5, Anton V Manuilov5, Bo Yan5, Gregory O Staples6, Da Ren7, Alexander J Veach7, Dongdong Wang8, Wael Yared8, Zoran Sosic9, Yan Wang9, Li Zang9, Anthony M Leone10, Peiran Liu10, Richard Ludwig10, Li Tao10, Wei Wu10, Ahmet Cansizoglu11, Andrew Hanneman11, Greg W Adams12, Irina Perdivara12, Hunter Walker12, Margo Wilson12, Arnd Brandenburg13, Nick DeGraan-Weber14, Stefano Gotta13, Joe Shambaugh14, Melissa Alvarez15, X Christopher Yu15, Li Cao16, Chun Shao16, Andrew Mahan17, Hirsh Nanda17, Kristen Nields17, Nancy Nightlinger3, Helena Maria Barysz18, Michael Jahn18, Ben Niu19, Jihong Wang19, Gabriella Leo20, Nunzio Sepe20, Yan-Hui Liu21, Bhumit A Patel21, Douglas Richardson21, Yi Wang21, Daniela Tizabi1,2, Oleg V Borisov22, Yali Lu22, Ernest L Maynard22, Albrecht Gruhler23, Kim F Haselmann23, Thomas N Krogh23, Carsten P Sönksen23, Simon Letarte24, Sean Shen24, Kristin Boggio25, Keith Johnson25, Wenqin Ni25, Himakshi Patel25, David Ripley25, Jason C Rouse25, Ying Zhang25, Carly Daniels26, Andrew Dawdy26, Olga Friese26, Thomas W Powers26, Justin B Sperry26, Josh Woods26, Eric Carlson27, K Ilker Sen27, St John Skilton27, Michelle Busch28, Anders Lund28, Martha Stapels28, Xu Guo29, Sibylle Heidelberger29, Harini Kaluarachchi29, Sean McCarthy30, John Kim31, Jing Zhen31, Ying Zhou31, Sarah Rogstad32, Xiaoshi Wang32, Jing Fang33, Weibin Chen33, Ying Qing Yu33, John G Hoogerheide34, Rebecca Scott34, Hua Yuan34.
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 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.Keywords: MAM Consortium; NISTmAb; multi-attribute method; new peak detection; purity testing
Year: 2021 PMID： 33710905 DOI： 10.1021/jasms.0c00415
Source DB: PubMed Journal: J Am Soc Mass Spectrom ISSN： 1044-0305 Impact factor: 3.109