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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
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
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001-es BibID:	BIBFORM084931
Első szerző:	Szekrényes Ákos (vegyészmérnök)
Cím:	Multi-Site N-glycan mapping study 1: Capillary electrophoresis ? laser induced fluorescence / Szekrényes Ákos, Park SungAe Suhr, Santos Marcia, Lew Clarence, Jones Aled, Haxo Ted, Kimzey Michael, Pourkaveh Shiva, Szabó Zoltán, Sosic Zoran, Feng Peng, Váradi Csaba, de l'Escaille François, Falmagne Jean-Bernard, Sejwal Preeti, Niedringhaus Thomas, Michels David, Freckleton Gordon, Hamm Melissa, Manuilov Anastasiya, Schwartz Melissa, Luo Jiann-Kae, van Dyck Jonathan, Leung Pui-King, Olajos Marcell, Gu Yingmei, Gao Kai, Wang Wenbo, Wegstein Jo, Tep Samnang, Guttman András
Dátum:	2016
ISSN:	1942-0862 1942-0870
Megjegyzések:	An international team that included 20 independent laboratories from biopharmaceutical companies, universities, analytical contract laboratories and national authorities in the United States, Europe and Asia was formed to evaluate the reproducibility of sample preparation and analysis of N-glycans using capillary electrophoresis of 8-aminopyrene1,3,6-trisulfonic acid (APTS)-labeled glycans with laser induced fluorescence (CE-LIF) detection (16 sites) and ultra highperformance liquid chromatography (UHPLC, 12 sites; results to be reported in a subsequent publication). All participants used the same lot of chemicals, samples, reagents, and columns/capillaries to run their assays. Migration time, peak area and peak area percent values were determined for all peaks with >0.1% peak area. Our results demonstrated low variability and high reproducibility, both, within any given site as well across all sites, which indicates that a standard N-glycan analysis platform appropriate for general use (clone selection, process development, lot release, etc.) within the industry can be established.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Biotherapeutics Capillary electrophoresis Intercompany study N-glycans
Megjelenés:	mAbs. - 8 : 1 (2016), p. 56-64. -
További szerzők:	Park, SungAe Suhr Santos, Marcia Lew, Clarence Jones, Aled Haxo, Ted Kimzey, Michael Pourkaveh, Shiva Szabó Zoltán Sosic, Zoran Feng, Peng Váradi Csaba (1988-) (molekuláris biológus) de l'Escaille, François Falmagne, Jean-Bernard Sejwal, Preeti Niedringhaus, Thomas Michels, David Freckleton, Gordon Hamm, Melissa Manuilov, Anastasiya Schwartz, Melissa Luo, Jiann-Kae van Dyck, Jonathan Leung, Pui-King Olajos Marcell Gu, Yingmei Gao, Kai Wang, Wenbo Wegstein, Jo Tep, Samnang Guttman András (1954-) (vegyészmérnök)
Pályázati támogatás:	K 116263 NKFIH
Internet cím:	Szerző által megadott URL DOI Intézményi repozitóriumban (DEA) tárolt változat
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001-es BibID:	BIBFORM077852
035-os BibID:	(PMID)29330871 (Scopus)85041568961 (WOS)000429417500010
Első szerző:	Szekrényes Ákos (vegyészmérnök)
Cím:	Multi-site N-Glycan mapping study 2 : UHPLC / Ákos Szekrényes, SungAe Suhr Park, Eoin Cosgrave, Aled Jones, Ted Haxo, Michael Kimzey, Shiva Pourkaveh, Zoltán Szabó, Zoran Sosic, Peng Feng, Preeti Sejwal, Kelsey Dent, David Michels, Gordon Freckleton, Jun Qian, Catherine Lancaster, Toni Duffy, Melissa Schwartz, Jiann-Kae Luo, Jonathan van Dyck, Pui-King Leung, Marcell Olajos, Ronald Kowle, Kai Gao, Wenbo Wang, Jo Wegstein, Samnang Tep, Apolka Domokos, Csaba Váradi, András Guttman
Dátum:	2018
ISSN:	0173-0835 1522-2683
Megjegyzések:	In the first part of this publication, the results from an international study evaluating theprecision (i.e., repeatability and reproducibility) of N-glycosylation analysis using capillaryelectrophoresis of APTS-labeled N-glycans were presented. The corresponding resultsfrom ultra-high performance liquid chromatography (UHPLC) with fluorescence detectionare presented here from 12 participating sites. All participants used the same lot of samples,reagents, and columns to perform the assays. Elution time, peak area and peak areapercent values were determined for all peaks 0.1% peak area, and statistical analysis wasperformed following ISO 5725-2 guideline principles. The results demonstrated adequatereproducibility, within any given site as well across all sites, indicating that standardUHPLC-based N-glycan analysis platforms are appropriate for general use
Tárgyszavak:	Orvostudományok Elméleti orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk 2-AB Biotherapeutics Intercompany study N-glycans UHPLC
Megjelenés:	Electrophoresis. - 39 : 7 (2018), p. 998-1005. -
További szerzők:	Park, SungAe Suhr Cosgrave, Eoin Jones, Aled Haxo, Ted Kimzey, Michael Pourkaveh, Shiva Szabó Zoltán (orvos) Sosic, Zoran Feng, Peng Sejwal, Preeti Dent, Kelsey Michels, David Freckleton, Gordon Qian, Jun Lancaster, Catherine Duffy, Toni Schwartz, Melissa Luo, Jiann-Kae van Dyck, Jonathan Leung, Pui-King Olajos Marcell Kowle, Ronald Gao, Kai Wang, Wenbo Wegstein, Jo Tep, Samnang Domokos Apolka Váradi Csaba (1988-) (molekuláris biológus) Guttman András (1954-) (vegyészmérnök)
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