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NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods

Molecular & cellular proteomics, 2020-01, Vol.19 (1), p.11-30 [Peer Reviewed Journal]

2020 © 2020 De Leoz et al. ;2020 De Leoz et al. ;Distributed under a Creative Commons Attribution 4.0 International License ;2020 De Leoz et al. 2020 De Leoz et al. ;ISSN: 1535-9476 ;EISSN: 1535-9484 ;DOI: 10.1074/mcp.RA119.001677 ;PMID: 31591262

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Title:
NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods
Author: Liu, Lily ; Yau, Hoi Kei ; Potter, Oscar ; Staples, Gregory O. ; Frenkel, Ruth ; Sosic, Zoran ; Zaia, Joseph ; Pengelley, Stuart ; Wiechmann, Anja ; Jabs, Wolfgang ; Froehlich, John W. ; Liu, Yaming ; Wang, Yaojun ; An, Hyun Joo ; Ruiz, Juan Echevarria ; Archer-Hartmann, Stephanie ; Lakos, Zsuzsanna ; An, Yanming ; Cipollo, John F. ; Pucic-Bakovic, Maja ; Štambuk, Jerko ; Lauc, Gordan ; Li, Xu ; Wang, Peng George ; Bock, Andreas ; Rapp, Erdmann ; Creskey, Marybeth ; Cyr, Terry D. ; Nakano, Miyako ; Leung, Pui-King Amy ; Link-Lenczowski, Paweł ; Jaworek, Jolanta ; Yang, Shuang ; Kelly, Tim ; Klapoetke, Song ; Cao, Rui ; Kim, Jin Young ; Lee, Hyun Kyoung ; Lee, Ju Yeon ; Yoo, Jong Shin ; Kozak, Radoslaw P. ; Urbanowicz, Paulina A. ; Packer, Nicolle H. ; Song, Xiaomin ; Everest-Dass, Arun ; Lattová, Erika ; Cajic, Samanta ; Alagesan, Kathirvel ; Kasali, Toyin ; Lindo, Viv ; Chen, Yuetian ; Amunugama, Ravi ; Jones, Richard ; Kato, Koichi ; Yuen, C.T. ; Harazono, Akira ; Shi, Xiaofeng ; Magnelli, Paula E. ; Mahal, Lara ; Harvey, David J. ; O'Flaherty, Roisin ; Rudd, Pauline M. ; Saldova, Radka ; Hecht, Elizabeth S. ; Menard, Daniele ; Saati, Andrew ; Merle, Christine ; Mast, Steven ; Tep, Sam ; Sekiya, Sadanori ; Shafer, Aaron ; de Vreugd, Peter ; Caron, Cassie ; Pradhan, Pralima ; Tan, Niclas Chiang ; Mechref, Yehia ; Patil, Sachin ; Rohrer, Jeffrey S. ; Dadke, Disha ; Lahori, Mohammedazam ; Zou, Chunxia ; Reiz, Béla ; Lebrilla, Carlito B. ; Guttman, Andras ; Kremkow, Benjamin G. ; Adamczyk, Barbara ; Jin, Chunsheng ; Karlsson, Niclas G. ; Örnros, Jessica ; Nilsson, Jonas ; Meyer, Bernd ; Komatsu, Emy ; Perreault, Helene ; Bodnar, Edward D. ; Said, Nassur ; Yang, Yang ; Haselberg, Rob ; Leone, Joseph W. ; Yuan, Hua ; Stein, Stephen E.
Subjects: Analytical chemistry ; Antibodies, Monoclonal - chemistry ; Antibodies, Monoclonal - metabolism ; Biochemistry & Molecular Biology ; Biochemistry and Molecular Biology ; Biokemi och molekylärbiologi ; Biological Products ; Biopharmaceutics - methods ; Chemical Sciences ; Clinical Laboratory Medicine ; fluorescence ; glycan ; glycomic analysis ; Glycomics ; Glycomics - methods ; glycopeptide ; Glycopeptides - metabolism ; glycoproteins ; Glycosylation ; Humans ; identification ; interlaboratory study ; Klinisk laboratoriemedicin ; Laboratories ; lc-ms/ms ; mass spectrometry ; NISTmAb ; Polysaccharides - metabolism ; profiles ; protein ; Protein Processing, Post-Translational ; Proteomics - methods ; quantification ; quantitation ; reference antibody ; therapeutic antibodies
Is Part Of: Molecular & cellular proteomics, 2020-01, Vol.19 (1), p.11-30
Description: A broad-based interlaboratory study of glycosylation profiles of a reference and modified IgG antibody involving 103 reports from 76 laboratories. [Display omitted] Highlights •A broad-based interlaboratory study of the glycosylation of a reference antibody: NISTmAb.•103 reports were received from 76 diverse laboratories worldwide.•Analysis involved two samples, the NISTmAb and an enzymatically modified sample, enabling within-lab separation of random and systematic errors using the “Youden two-sample” method.•Consensus values were derived and similar performance across all experimental methods was noted. Glycosylation is a topic of intense current interest in the development of biopharmaceuticals because it is related to drug safety and efficacy. This work describes results of an interlaboratory study on the glycosylation of the Primary Sample (PS) of NISTmAb, a monoclonal antibody reference material. Seventy-six laboratories from industry, university, research, government, and hospital sectors in Europe, North America, Asia, and Australia submitted a total of 103 reports on glycan distributions. The principal objective of this study was to report and compare results for the full range of analytical methods presently used in the glycosylation analysis of mAbs. Therefore, participation was unrestricted, with laboratories choosing their own measurement techniques. Protein glycosylation was determined in various ways, including at the level of intact mAb, protein fragments, glycopeptides, or released glycans, using a wide variety of methods for derivatization, separation, identification, and quantification. Consequently, the diversity of results was enormous, with the number of glycan compositions identified by each laboratory ranging from 4 to 48. In total, one hundred sixteen glycan compositions were reported, of which 57 compositions could be assigned consensus abundance values. These consensus medians provide community-derived values for NISTmAb PS. Agreement with the consensus medians did not depend on the specific method or laboratory type. The study provides a view of the current state-of-the-art for biologic glycosylation measurement and suggests a clear need for harmonization of glycosylation analysis methods.
Publisher: United States: Elsevier Inc
Language: English
Identifier: ISSN: 1535-9476
EISSN: 1535-9484
DOI: 10.1074/mcp.RA119.001677
PMID: 31591262
Source: Geneva Foundation Free Medical Journals at publisher websites
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PubMed Central
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NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods

2020 © 2020 De Leoz et al. ;2020 De Leoz et al. ;Distributed under a Creative Commons Attribution 4.0 International License ;2020 De Leoz et al. 2020 De Leoz et al. ;ISSN: 1535-9476 ;EISSN: 1535-9484 ;DOI: 10.1074/mcp.RA119.001677 ;PMID: 31591262

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