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1.
001-es BibID:
BIBFORM092901
035-os BibID:
(WoS)000518794300002 (Scopus)85076683169
Első szerző:
De Leoz, Maria Lorna A.
Cím:
NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods / Maria Lorna A. De Leoz, David L. Duewer, Adam Fung, Lily Liu, Hoi Kei Yau, Oscar Potter, Gregory O. Staples, Kenichiro Furuki, Ruth Frenkel, Yunli Hu, Zoran Sosic, Peiqing Zhang, Friedrich Altmann, Clemens Grunwald-Grube, Chun Shao, Joseph Zaia, Waltraud Evers, Stuart Pengelley, Detlev Suckau, Anja Wiechmann, Anja Resemann, Wolfgang Jabs, Alain Beck, John W. Froehlich, Chuncui Huang, Yan Li, Yaming Liu, Shiwei Sun, Yaojun Wang, Youngsuk Seo, Hyun Joo An, Niels-Christian Reichardt, Juan Echevarria Ruiz, Stephanie Archer-Hartmann, Parastoo Azadi, Len Bell, Zsuzsanna Lakos, Yanming An, John F. Cipollo, Maja Pucic-Bakovic, Jerko Štambuk, Gordan Lauc, Xu Li, Peng George Wang, Andreas Bock, René Hennig, Erdmann Rapp, Marybeth Creskey, Terry D. Cyr, Miyako Nakano, Taiki Sugiyama, Pui-King Amy Leung, Paweł Link-Lenczowski, Jolanta Jaworek, Shuang Yang, Hui Zhang, Tim Kelly, Song Klapoetke, Rui Cao, Jin Young Kim, Hyun Kyoung Lee, Ju Yeon Lee, Jong Shin Yoo, Sa-Rang Kim, Soo-Kyung Suh, Noortje de Haan, David Falck, Guinevere S. M. Lageveen-Kammeijer, Manfred Wuhrer, Robert J. Emery, Radoslaw P. Kozak, Li Phing Liew, Louise Royle, Paulina A. Urbanowicz, Nicolle H. Packer, Xiaomin Song, Arun Everest-Dass, Erika Lattová, Samanta Cajic, Kathirvel Alagesan, Daniel Kolarich, Toyin Kasali, Viv Lindo, Yuetian Chen, Kudrat Goswami, Brian Gau, Ravi Amunugama, Richard Jones, Corné J. M. Stroop, Koichi Kato, Hirokazu Yagi, Sachiko Kondo, C. T. Yuen, Akira Harazono, Xiaofeng Shi, Paula E. Magnelli, Brian T. Kasper, Lara Mahal, David J. Harvey, Roisin O'Flaherty, Pauline M. Rudd, Radka Saldova, Elizabeth S. Hecht, David C. Muddiman, Jichao Kang, Prachi Bhoskar, Daniele Menard, Andrew Saati, Christine Merle, Steven Mast, Sam Tep, Jennie Truong, Takashi Nishikaze, Sadanori Sekiya, Aaron Shafer, Sohei Funaoka, Masaaki Toyoda, Peter de Vreugd, Cassie Caron, Pralima Pradhan, Niclas Chiang Tan, Yehia Mechref, Sachin Patil, Jeffrey S. Rohrer, Ranjan Chakrabarti, Disha Dadke, Mohammedazam Lahori, Chunxia Zou, Christopher Cairo, Béla Reiz, Randy M. Whittal, Carlito B. Lebrilla, Lauren Wu, Andras Guttman, Marton Szigeti, Benjamin G. Kremkow, Kelvin H. Lee, Carina Sihlbom, Barbara Adamczyk, Chunsheng Jin, Niclas G. Karlsson, Jessica Örnros, Göran Larson, Jonas Nilsson, Bernd Meyer, Alena Wiegandt, Emy Komatsu, Helene Perreault, Edward D. Bodnar, Nassur Said, Yannis-Nicolas Francois, Emmanuelle Leize-Wagner, Sandra Maier, Anne Zeck, Albert J. R. Heck, Yang Yang, Rob Haselberg, Ying Qing Yu, William Alley, Joseph W. Leone, Hua Yuan, Stephen E. Stein
Dátum:
2020
ISSN:
1535-9476
Megjegyzések:
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.
Tárgyszavak:
Orvostudományok
Elméleti orvostudományok
idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:
Molecular & Cellular Proteomics. - 19 : 1 (2020), p. 11-30. -
További szerzők:
Duewer, David L.
Fung, Adam
Liu, Lily
Yau, Hoi Kei
Potter, Oscar
Staples, Gregory O.
Furuki, Kenichiro
Frenkel, Ruth
Hu, Yunli
Sosic, Zoran
Zhang, Peiqing
Altmann, Friedrich
Grunwald-Grube, Clemens
Shao, Chun
Zaia, Joseph
Evers, Waltraud
Pengelley, Stuart
Suckau, Detlev
Wiechmann, Anja
Resemann, Anja
Jabs, Wolfgang
Beck, Alain
Froehlich, John W.
Huang, Chuncui
Li, Yan
Liu, Yaming
Sun, Shiwei
Wang, Yaojun
Seo, Youngsuk
An, Hyun Joo
Reichardt, Niels-Christian
Ruiz, Juan Echevarria
Archer-Hartmann, Stephanie
Azadi, Parastoo
Bell, Len
Lakos Zsuzsanna
An, Yanming
Cipollo, John F.
Pucic-Bakovic, Maja
Stambuk, Jerko
Lauc, Gordan
Li, Xu
Wang, Peng George
Bock, Andreas
Hennig, René
Rapp, Erdmann
Creskey, Marybeth
Cyr, Terry D.
Nakano, Miyako
Sugiyama, Taiki
Leung, Pui-King
Link-Lenczowski, Paweł
Jaworek, Jolanta
Yang, Shuang
Zhang, Hui
Kelly, Tim
Klapoetke, Song
Cao, Rui
Kim, Jiyoung
Lee, Hyun Kyoung
Lee, Ju Yeon
Yoo, Jong Shin
Kim, Sa-Rang
Suh, Soo-Kyung
de Haan, Noortje
Falck, David
Lageveen-Kammeijer, Guinevere S. M.
Wuhrer, Manfred
Emery, Robert J.
Kozak, Radoslaw P.
Liew, Li Phing
Royle, Louise
Urbanowicz, Paulina A.
Packer, Nicolle
Song, Xiaomin
Everest-Dass, Arun
Lattová, Erika
Cajic, Samanta
Alagesan, Kathirvel
Kolarich, Daniel
Kasali, Toyin
Lindo, Viv
Chen, Yuetian
Goswami, Kudrat
Gau, Brian
Amunugama, Ravi
Jones, Richard
Stroop, Corné J. M.
Kato, Koichi
Yagi, Hirokazu
Kondo, Sachiko
Yuen, C. T.
Harazono, Akira
Shi, Xiaofeng
Magnelli, Paula E.
Kasper, Brian T.
Mahal, Lara
Harvey, David J.
O'Flaherty, Roisin
Rudd, Pauline M.
Saldova, Radka
Hecht, Elizabeth S.
Muddiman, David C.
Kang, Jichao
Bhoskar, Prachi
Menard, Daniele
Saati, Andrew
Merle, Christine
Mast, Steven
Tep, Sam
Truong, Jennie
Nishikaze, Takashi
Sekiya, Sadanori
Shafer, Aaron
Funaoka, Sohei
Toyoda, Masaaki
de Vreugd, Peter
Caron, Cassie
Pradhan, Pralima
Tan, Niclas Chiang
Mechref, Yehia
Patil, Sachin
Rohrer, Jeffrey S.
Chakrabarti, Ranjan
Dadke, Disha
Lahori, Mohammedazam
Zou, Chunxia
Cairo, Christopher
Reiz, Béla
Whittal, Randy M.
Lebrilla, Carlito B.
Wu, Lauren
Guttman András (1954-) (vegyészmérnök)
Szigeti Márton (1986-) (környezetmérnök)
Kremkow, Benjamin G.
Lee, Kelvin H.
Sihlbom, Carina
Adamczyk, Barbara
Jin, Chunsheng
Karlsson, Niclas G.
Örnros, Jessica
Larson, Göran
Nilsson, Jonas
Meyer, Bernd
Wiegandt, Alena
Komatsu, Emy
Perreault, Helene
Bodnar, Edward D.
Said, Nassur
Francois, Yannis-Nicolas
Leize-Wagner, Emmanuelle
Maier, Sandra
Zeck, Anne
Heck, Albert J. R.
Yang, Yang
Haselberg, Rob
Yu, Ying Qing
Alley, William
Leone, Joseph W.
Yuan, Hua
Stein, Stephen E.
Pályázati támogatás:
NKFIH-K 116263
NKFIH
GINOP-2.3.2- 15-2016-00017
GINOP
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