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dc.contributor.authorDe Leoz, Maria Lorna A
dc.contributor.authorDuewer, David L
dc.contributor.authorFung, Adam
dc.contributor.authorLiu, Lily
dc.contributor.authorYau, Hoi Kei
dc.contributor.authorPotter, Oscar
dc.contributor.authorStaples, Gregory O
dc.contributor.authorFuruki, Kenichiro
dc.contributor.authorFrenkel, Ruth
dc.contributor.authorHu, Yunli
dc.contributor.authorSosic, Zoran
dc.contributor.authorZhang, Peiqing
dc.contributor.authorAltmann, Friedrich
dc.contributor.authorGrunwald-Grube, Clemens
dc.contributor.authorShao, Chun
dc.contributor.authorZaia, Joseph
dc.contributor.authorEvers, Waltraud
dc.contributor.authorPengelley, Stuart
dc.contributor.authorSuckau, Detlev
dc.contributor.authorWiechmann, Anja
dc.contributor.authorResemann, Anja
dc.contributor.authorJabs, Wolfgang
dc.contributor.authorBeck, Alain
dc.contributor.authorFroehlich, John W
dc.contributor.authorHuang, Chuncui
dc.contributor.authorLi, Yan
dc.contributor.authorLiu, Yaming
dc.contributor.authorSun, Shiwei
dc.contributor.authorWang, Yaojun
dc.contributor.authorSeo, Youngsuk
dc.contributor.authorAn, Hyun Joo
dc.contributor.authorReichardt, Niels-Christian
dc.contributor.authorRuiz, Juan Echevarria
dc.contributor.authorArcher-Hartmann, Stephanie
dc.contributor.authorAzadi, Parastoo
dc.contributor.authorBell, Len
dc.contributor.authorLakos, Zsuzsanna
dc.contributor.authorAn, Yanming
dc.contributor.authorCipollo, John F
dc.contributor.authorPucic-Bakovic, Maja
dc.contributor.authorStambuk, Jerko
dc.contributor.authorLauc, Gordan
dc.contributor.authorLi, Xu
dc.contributor.authorWang, Peng George
dc.contributor.authorBock, Andreas
dc.contributor.authorHennig, Rene
dc.contributor.authorRapp, Erdmann
dc.contributor.authorCreskey, Marybeth
dc.contributor.authorCyr, Terry D
dc.contributor.authorNakano, Miyako
dc.contributor.authorSugiyama, Taiki
dc.contributor.authorLeung, Pui-King Amy
dc.contributor.authorLink-Lenczowski, Pawe
dc.contributor.authorJaworek, Jolanta
dc.contributor.authorYang, Shuang
dc.contributor.authorZhang, Hui
dc.contributor.authorKelly, Tim
dc.contributor.authorKlapoetke, Song
dc.contributor.authorCao, Rui
dc.contributor.authorKim, Jin Young
dc.contributor.authorLee, Hyun Kyoung
dc.contributor.authorLee, Ju Yeon
dc.contributor.authorYoo, Jong Shin
dc.contributor.authorKim, Sa-Rang
dc.contributor.authorSuh, Soo-Kyung
dc.contributor.authorde Haan, Noortje
dc.contributor.authorFalck, David
dc.contributor.authorLageveen-Kammeijer, Guinevere SM
dc.contributor.authorWuhrer, Manfred
dc.contributor.authorEmery, Robert J
dc.contributor.authorKozak, Radoslaw P
dc.contributor.authorLiew, Li Phing
dc.contributor.authorRoyle, Louise
dc.contributor.authorUrbanowicz, Paulina A
dc.contributor.authorPacker, Nicolle H
dc.contributor.authorSong, Xiaomin
dc.contributor.authorEverest-Dass, Arun
dc.contributor.authorLattova, Erika
dc.contributor.authorCajic, Samanta
dc.contributor.authorAlagesan, Kathirvel
dc.contributor.authorKolarich, Daniel
dc.contributor.authorKasali, Toyin
dc.contributor.authorLindo, Viv
dc.contributor.authorChen, Yuetian
dc.contributor.authorGoswami, Kudrat
dc.contributor.authorGau, Brian
dc.contributor.authorAmunugama, Ravi
dc.contributor.authorJones, Richard
dc.contributor.authorStroop, Corn JM
dc.contributor.authorKato, Koichi
dc.contributor.authorYagi, Hirokazu
dc.contributor.authorKondo, Sachiko
dc.contributor.authorYuen, CT
dc.contributor.authorHarazono, Akira
dc.contributor.authorShi, Xiaofeng
dc.contributor.authorMagnelli, Paula E
dc.contributor.authorKasper, Brian T
dc.contributor.authorMahal, Lara
dc.contributor.authorHarvey, David J
dc.contributor.authorO'Flaherty, Roisin
dc.contributor.authorRudd, Pauline M
dc.contributor.authorSaldova, Radka
dc.contributor.authorHecht, Elizabeth S
dc.contributor.authorMuddiman, David C
dc.contributor.authorKang, Jichao
dc.contributor.authorBhoskar, Prachi
dc.contributor.authorMenard, Daniele
dc.contributor.authorSaati, Andrew
dc.contributor.authorMerle, Christine
dc.contributor.authorMast, Steven
dc.contributor.authorTep, Sam
dc.contributor.authorTruong, Jennie
dc.contributor.authorNishikaze, Takashi
dc.contributor.authorSekiya, Sadanori
dc.contributor.authorShafer, Aaron
dc.contributor.authorFunaoka, Sohei
dc.contributor.authorToyoda, Masaaki
dc.contributor.authorde Vreugd, Peter
dc.contributor.authorCaron, Cassie
dc.contributor.authorPradhan, Pralima
dc.contributor.authorTan, Niclas Chiang
dc.contributor.authorMechref, Yehia
dc.contributor.authorPatil, Sachin
dc.contributor.authorRohrer, Jeffrey S
dc.contributor.authorChakrabarti, Ranjan
dc.contributor.authorDadke, Disha
dc.contributor.authorLahori, Mohammedazam
dc.contributor.authorZou, Chunxia
dc.contributor.authorCairo, Christopher
dc.contributor.authorReiz, Bela
dc.contributor.authorWhittal, Randy M
dc.contributor.authorLebrilla, Carlito B
dc.contributor.authorWu, Lauren
dc.contributor.authorGuttman, Andras
dc.contributor.authorSzigeti, Marton
dc.contributor.authorKremkow, Benjamin G
dc.contributor.authorLee, Kelvin H
dc.contributor.authorSihlbom, Carina
dc.contributor.authorAdamczyk, Barbara
dc.contributor.authorJin, Chunsheng
dc.contributor.authorKarlsson, Niclas G
dc.contributor.authorOrnros, Jessica
dc.contributor.authorLarson, Gran
dc.contributor.authorNilsson, Jonas
dc.contributor.authorMeyer, Bernd
dc.contributor.authorWiegandt, Alena
dc.contributor.authorKomatsu, Emy
dc.contributor.authorPerreault, Helene
dc.contributor.authorBodnar, Edward D
dc.contributor.authorSaid, Nassur
dc.contributor.authorFrancois, Yannis-Nicolas
dc.contributor.authorLeize-Wagner, Emmanuelle
dc.contributor.authorMaier, Sandra
dc.contributor.authorZeck, Anne
dc.contributor.authorHeck, Albert JR
dc.contributor.authorYang, Yang
dc.contributor.authorHaselberg, Rob
dc.contributor.authorYu, Ying Qing
dc.contributor.authorAlley, William
dc.contributor.authorLeone, Joseph W
dc.contributor.authorYuan, Hua
dc.contributor.authorStein, Stephen E
dc.date.accessioned2020-04-01T23:21:31Z
dc.date.available2020-04-01T23:21:31Z
dc.date.issued2020
dc.identifier.issn1535-9476
dc.identifier.doi10.1074/mcp.RA119.001677
dc.identifier.urihttp://hdl.handle.net/10072/392891
dc.description.abstractGlycosylation 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.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherAmerican Society for Biochemistry and Molecular Biology
dc.relation.ispartofpagefrom11
dc.relation.ispartofpageto30
dc.relation.ispartofissue1
dc.relation.ispartofjournalMolecular & Cellular Proteomics
dc.relation.ispartofvolume19
dc.subject.fieldofresearchBiological sciences
dc.subject.fieldofresearchGlycobiology
dc.subject.fieldofresearchGlycoconjugates
dc.subject.fieldofresearchAnalytical biochemistry
dc.subject.fieldofresearchProteomics and intermolecular interactions (excl. medical proteomics)
dc.subject.fieldofresearchMedical biochemistry - proteins and peptides (incl. medical proteomics)
dc.subject.fieldofresearchcode31
dc.subject.fieldofresearchcode310107
dc.subject.fieldofresearchcode340405
dc.subject.fieldofresearchcode310101
dc.subject.fieldofresearchcode310109
dc.subject.fieldofresearchcode320506
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.subject.keywordsBiochemical Research Methods
dc.subject.keywordsBiochemistry & Molecular Biology
dc.subject.keywordsGlycomics
dc.titleNIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationDe Leoz, et al., NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods, Molecular & Cellular Proteomics, 2020, 19 (1), pp. 11-30
dcterms.licensehttp://creativecommons.org/licenses/by/4.0
dc.date.updated2020-04-01T23:07:55Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© 2020 De Leoz et al. Published by The American Society for Biochemistry and Molecular Biology, Inc. This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
gro.hasfulltextFull Text
gro.griffith.authorKolarich, Daniel
gro.griffith.authorPacker, Nicki
gro.griffith.authorEverest-Dass, Arun


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