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

作者：Maria Lorna A. De Leoz, David L. Duewer, Adam Fung, Lily Liu, Hoi Kei Yau, Oscar G. 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 Pučić‐Baković, Jerko Štambuk, Gordan Lauc, Xu Li, Peng George Wang, Andreas Böck, 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, R. J. Neil 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, R. Brad Jones, Corné J.M. Stroop, Koichi Kato, Hirokazu Yagi, Sachiko Kondo, C-T. Yuen, Akira Harazono, Xiaofeng Shi, Paula Magnelli, Brian Kasper, Lara K. Mahal, David J. Harvey, Róisín O’Flaherty, Pauline M. Rudd, Radka Saldova, Elizabeth S. Hecht, David C. Muddiman, Jichao Kang, Prachi Bhoskar, Daniele Menard, Andrew Saati, Christine Merle, Steven W. Mast, Sam Tep, Jennie Truong, Takashi Nishikaze, Sadanori Sekiya, Aaron B. A. 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 W. Cairo, Béla Reiz, Randy M. Whittal, Carlito B. Lebrilla, Lauren Wu, András Guttman, Márton Szigeti, Benjamin G. Kremkow, Kelvin H. Lee, Carina Sihlbom, B Adamczyk, Chunsheng Jin, Niclas G. Karlsson, Jessica Örnros, Göran Larson, Jonas Nilsson, Bernd Meyer, Alena Wiegandt, Emy Komatsu, Hélène Perreault, Edward Bodnar, Nassur Saïd, Yannis‐Nicolas François, Emmanuelle Leize‐Wagner, Sandra Maier, Anne Zeck, Albert J. R. Heck, Yang Yang, Rob Haselberg, Ying Yu, William R. Alley, Joseph W. Leone, Hua Yuan, Stephen E. Stein · 发表于：Molecular & Cellular Proteomics · 年份：2019 · DOI：10.1074/mcp.ra119.001677 · 被引用次数：126 · 研究领域：Glycosylation and Glycoproteins Research、Monoclonal and Polyclonal Antibodies Research、Analytical Chemistry and Chromatography

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...