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  NIST interlaboratory study on glycosylation analysis of monoclonal antibodies : comparison of results from diverse analytical methods

Leoz, D., A., M. L., Duewer, D. L., Fung, A., Liu, L., Yau, H. K., et al. (2020). NIST interlaboratory study on glycosylation analysis of monoclonal antibodies: comparison of results from diverse analytical methods. Molecular and Cellular Proteomics, 19(1), 11-30. doi:10.1074/mcp.RA119.001677.

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Item Permalink: http://hdl.handle.net/21.11116/0000-0005-7F39-E Version Permalink: http://hdl.handle.net/21.11116/0000-0005-7F3A-D
Genre: Journal Article

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Leoz, De, Author
A., Maria Lorna, Author
Duewer, David L., Author
Fung, Adam, Author
Liu, Lily, Author
Yau, Hoi Kei, Author
Potter, Oscar, Author
Staples, Gregory O., Author
Furuki, Kenichiro, Author
Frenkel, Ruth, Author
Hu, Yunli, Author
Sosic, Zoran, Author
Zhang, Peiqing, Author
Altmann, Friedrich, Author
Gruber, Clemens, Author
Shao, Chun, Author
Zaia, Joseph, Author
Evers, Waltraud, Author
Pangelley, Stuart, Author
Suckau, Detlev, Author
Wiechmann, Anja, AuthorResemann, Anja, AuthorJabs, Wolfgang, AuthorBeck, Alain, AuthorFroehlich, John W, AuthorHuang, ChunCui, AuthorLi, Yan, AuthorLiu, YaMing, AuthorSun, Shiwei, AuthorWang, Yaojun, AuthorSeo, Youngsuk, AuthorAn, Hyun Joo, AuthorReichardt, Niels-Christian, AuthorRuiz, Juan Echevarria, AuthorArcher‑Hartmann, Stephanie, AuthorAzadi, Parastoo, AuthorBell, Len, AuthorLakos, Zsuzsanna, AuthorAn, Yanming, AuthorCipollo, John F, AuthorPučić-Baković, Maja, AuthorŠtambuk, Jerko, AuthorLauc, Gordan, AuthorLi, Xu, AuthorWang, Peng George, AuthorBock, Andreas, AuthorHennig, René, AuthorRapp, Erdmann, AuthorCreskey, Marybeth, AuthorCyr, Terry, AuthorNakano, Miyako, AuthorSugiyama, Taiki, AuthorLeung, Pui‑King Amy, AuthorLink‑Lenczowski, Paweł, AuthorJaworek, Jolanta, AuthorYang, Shuang Jake, AuthorZhang, Hui, AuthorKelly, Tim, AuthorKlapoetke, Song, AuthorCao, Rui, AuthorKim, Jin Young, AuthorLee, Hyun Kyung, AuthorLee, Juyeon, AuthorYoo, Jong Shin, AuthorKim, Sa‑Rang, AuthorSuh, Soo‑Kyung, Authorde Haan, Noortje, AuthorFalck, David, AuthorLageveen-Kammeijer, Guinevere S.M., AuthorWuhrer, Manfred, AuthorEmery, Robert J., AuthorKozak, Radoslaw P., AuthorLiew, Li Phing, AuthorRoyle, Louise, AuthorUrbanowicz, Paulina A., AuthorPacker, Nicolle, AuthorSong, Xiaomin, AuthorEverest-Dass, Arun, AuthorLattová, Erika, AuthorCajic, Samanta, AuthorAlagesan, Kathirvel1, Author              Kolarich, Daniel1, Author              Kasali, Toyin, AuthorLindo, Viv, AuthorChen, Yuetian, AuthorGoswami, Kudrat, AuthorGau, Brian, AuthorAmunugama, Ravi, AuthorJones, Richard, AuthorStroop, Corné J. M., AuthorKato, Koichi, AuthorYagi, Hirokazu, AuthorKondo, Sachiko, AuthorYuen, CT, AuthorHarazono, Akira, AuthorShi, Xiaofeng, AuthorMagnelli, Paula, AuthorKasper, Brian T, AuthorMahal, Lara K., AuthorHarvey, David J., AuthorO'Flaherty, Roisin, AuthorRudd, Pauline M., AuthorSaldova, Radka, AuthorHecht, Elizabeth S., AuthorMuddiman, David C., AuthorKang, Jichao, AuthorBhoskar, Prachi, AuthorMenard, Daniele, AuthorSaati, Andrew, AuthorMerle, Christine, AuthorMast, Steven, AuthorTep, Sam, AuthorTruong, Jennie, AuthorNishikaze, Takashi, AuthorSekiya, Sadanori, AuthorShafer, Aaron, AuthorFunaoka, Sohei, AuthorToyoda, Masaaki, Authorde Vreugd, Peter, AuthorCaron, Cassie, AuthorPradhan, Pralima, AuthorTan, Niclas Chiang, AuthorMechref, Yehia, AuthorPatil, Sachin, AuthorRohrer, Jeffrey S., AuthorChakrabarti, Ranjan, AuthorDadke, Disha, AuthorLahori, Mohammedazam, AuthorZou, Chunxia, AuthorCairo, Christopher W., AuthorReiz, Bela, AuthorWhittal, Randy M, AuthorLebrilla, Carlito, AuthorWu, Lauren D., AuthorGuttman, Andras, AuthorSzigeti, Marton, AuthorKremkow, Benjamin G., AuthorLee, Kelvin, AuthorSihlbom, Carina, AuthorAdamczyk, Barbara, AuthorJin, Chunsheng, AuthorKarlsson, Niclas G., AuthorÖrnros, Jessica, AuthorLarson, Göran, AuthorNilsson, Jonas, AuthorMeyer, Bernd, AuthorWiegandt, Alena, AuthorKomatsu, Emy, AuthorPerreault, Helene, AuthorBodnar, Edward D, AuthorSaid, Nassur, AuthorFrancois, Yannis‑Nicolas, AuthorLeize-Wagner, Emmanuelle, AuthorMaier, Sandra, AuthorZeck, Anne, AuthorHeck, Albert J. R., AuthorYang, Yang, AuthorHaselberg, Rob, AuthorYu, Ying Qing, AuthorAlley, William, AuthorLeone, Joseph W., AuthorYuan, Hua, AuthorStein, Stephen E., Author more..
Affiliations:
1Daniel Kolarich, Biomolekulare Systeme, Max Planck Institute of Colloids and Interfaces, Max Planck Society, ou_1863301              

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Free keywords: Glycomics; mass spectrometry; fluorescence; glycosylation; glycoproteins; glycan; glycopeptide; interlaboratory study; NISTmAb; reference antibody
 Abstract: Glycosylation is a topic of intense current interest in the development of biopharmaceuticals since 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.

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Language(s): eng - English
 Dates: 2019-10-072020
 Publication Status: Published in print
 Pages: -
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Title: Molecular and Cellular Proteomics
Source Genre: Journal
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Publ. Info: Bethesda, MD : American Society for Biochemistry and Molecular Biology
Pages: - Volume / Issue: 19 (1) Sequence Number: - Start / End Page: 11 - 30 Identifier: ISSN: 1535-9476