New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study

被引：33

作者：

Mouchahoir, Trina ^{[1
,2
]}

Schiel, John E. ^{[1
,2
]}

Rogers, Rich ^{[3
]}

Heckert, Alan ^{[1
]}

Place, Benjamin J. ^{[1
]}

Ammerman, Aaron ^{[4
]}

Li, Xiaoxiao ^{[4
]}

Robinson, Tom ^{[4
]}

Schmidt, Brian ^{[4
]}

Chumsae, Chris M. ^{[5
]}

Li, Xinbi ^{[5
]}

Manuilov, Anton, V ^{[5
]}

Yan, Bo ^{[5
]}

Staples, Gregory O. ^{[6
]}

Ren, Da ^{[7
]}

Veach, Alexander J. ^{[7
]}

Wang, Dongdong ^{[8
]}

Yared, Wael ^{[8
]}

Sosic, Zoran ^{[9
]}

Wang, Yan ^{[9
]}

Zang, Li ^{[9
]}

Leone, Anthony M. ^{[10
]}

Liu, Peiran ^{[10
]}

Ludwig, Richard ^{[10
]}

Tao, Li ^{[10
]}

Wu, Wei ^{[10
]}

Cansizoglu, Ahmet ^{[11
]}

Hanneman, Andrew ^{[11
]}

Adams, Greg W. ^{[12
]}

Perdivara, Irina ^{[12
]}

Walker, Hunter ^{[12
]}

Wilson, Margo ^{[12
]}

Brandenburg, Arnd ^{[13
]}

DeGraan-Weber, Nick ^{[14
]}

Gotta, Stefano ^{[13
]}

Shambaugh, Joe ^{[14
]}

Alvarez, Melissa ^{[15
]}

Yu, X. Christopher ^{[15
]}

Cao, Li ^{[16
]}

Shao, Chun ^{[16
]}

Mahan, Andrew ^{[17
]}

Nanda, Hirsh ^{[17
]}

Nields, Kristen ^{[17
]}

Nightlinger, Nancy ^{[3
]}

Barysz, Helena Maria ^{[18
]}

Jahn, Michael ^{[18
]}

Niu, Ben ^{[19
]}

Wang, Jihong ^{[19
]}

Leo, Gabriella ^{[20
]}

Sepe, Nunzio ^{[20
]}

机构：

[1] NIST, Gaithersburg, MD 20899 USA

[2] Inst Biosci & Biotechnol Res, Rockville, MD 20850 USA

[3] Just Evotech Biol, Seattle, WA 98109 USA

[4] AbbVie, Redwood City, CA 94063 USA

[5] AbbVie, Worcester, MA 01605 USA

[6] Agilent Technol, Santa Clara, CA 95008 USA

[7] Amgen Inc, Thousand Oaks, CA 91320 USA

[8] BioAnalytix, Cambridge, MA 02139 USA

[9] Biogen, Cambridge, MA 02142 USA

[10] Bristol Myers Squibb, Pennington, NJ 08534 USA

[11] Charles River Labs, Shrewsbury, MA 01801 USA

[12] FUJIFILM Diosynth Biotechnol, Morrisville, NC 27560 USA

[13] Genedata, CH-4053 Basel, Switzerland

[14] Genedata, Lexington, MA 02421 USA

[15] Genentech Inc, San Francisco, CA 94080 USA

[16] GSK, King Of Prussia, PA 19406 USA

[17] Janssen, Spring House, PA 19477 USA

[18] Lonza, CH-4057 Basel, Switzerland

[19] AstraZeneca, Gaithersburg, MD 20878 USA

[20] EMD Serono, I-00012 Rome, Italy

[21] Merck & Co Inc, Kenilworth, NJ 07033 USA

[22] Novavax Inc, Gaithersburg, MD 20878 USA

[23] Novo Nordisk, DK-2760 Malov, Denmark

[24] Pfizer, Lake Forest, IL 60045 USA

[25] Pfizer, Andover, MA 01810 USA

[26] Pfizer, Chesterfield, MO 63017 USA

[27] Prot Metr Inc, Cupertino, CA 95014 USA

[28] Sanofi, Framingham, MA 01701 USA

[29] SCIEX Ltd, Concord, ON L4K 4V8, Canada

[30] SCIEX Ltd, Framingham, MA 01701 USA

[31] Teva, W Chester, PA 19380 USA

[32] US FDA, Silver Spring, MD 20993 USA

[33] Waters, Milford, MA 01757 USA

[34] Zoetis, Kalamazoo, MI 49007 USA

来源：

JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY | 2021年 / 32卷 / 04期

关键词：

multi-attribute method; MAM Consortium; new peak detection; NISTmAb; purity testing; MULTIATTRIBUTE METHOD; MASS-SPECTROMETRY; QUALITY-CONTROL;

D O I：

10.1021/jasms.0c00415

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

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 purityindicating 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.

引用

页码：913 / 928

页数：16

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