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


ABSTRACT: 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.

SUBMITTER: De Leoz MLA 

PROVIDER: S-EPMC6944243 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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

De Leoz Maria Lorna A MLA   Duewer David L DL   Fung Adam A   Liu Lily L   Yau Hoi Kei HK   Potter Oscar O   Staples Gregory O GO   Furuki Kenichiro K   Frenkel Ruth R   Hu Yunli Y   Sosic Zoran Z   Zhang Peiqing P   Altmann Friedrich F   Grunwald-Grube Clemens C   Shao Chun C   Zaia Joseph J   Evers Waltraud W   Pengelley Stuart S   Suckau Detlev D   Wiechmann Anja A   Resemann Anja A   Jabs Wolfgang W   Beck Alain A   Froehlich John W JW   Huang Chuncui C   Li Yan Y   Liu Yaming Y   Sun Shiwei S   Wang Yaojun Y   Seo Youngsuk Y   An Hyun Joo HJ   Reichardt Niels-Christian NC   Ruiz Juan Echevarria JE   Archer-Hartmann Stephanie S   Azadi Parastoo P   Bell Len L   Lakos Zsuzsanna Z   An Yanming Y   Cipollo John F JF   Pucic-Bakovic Maja M   Štambuk Jerko J   Lauc Gordan G   Li Xu X   Wang Peng George PG   Bock Andreas A   Hennig René R   Rapp Erdmann E   Creskey Marybeth M   Cyr Terry D TD   Nakano Miyako M   Sugiyama Taiki T   Leung Pui-King Amy PA   Link-Lenczowski Paweł P   Jaworek Jolanta J   Yang Shuang S   Zhang Hui H   Kelly Tim T   Klapoetke Song S   Cao Rui R   Kim Jin Young JY   Lee Hyun Kyoung HK   Lee Ju Yeon JY   Yoo Jong Shin JS   Kim Sa-Rang SR   Suh Soo-Kyung SK   de Haan Noortje N   Falck David D   Lageveen-Kammeijer Guinevere S M GSM   Wuhrer Manfred M   Emery Robert J RJ   Kozak Radoslaw P RP   Liew Li Phing LP   Royle Louise L   Urbanowicz Paulina A PA   Packer Nicolle H NH   Song Xiaomin X   Everest-Dass Arun A   Lattová Erika E   Cajic Samanta S   Alagesan Kathirvel K   Kolarich Daniel D   Kasali Toyin T   Lindo Viv V   Chen Yuetian Y   Goswami Kudrat K   Gau Brian B   Amunugama Ravi R   Jones Richard R   Stroop Corné J M CJM   Kato Koichi K   Yagi Hirokazu H   Kondo Sachiko S   Yuen C T CT   Harazono Akira A   Shi Xiaofeng X   Magnelli Paula E PE   Kasper Brian T BT   Mahal Lara L   Harvey David J DJ   O'Flaherty Roisin R   Rudd Pauline M PM   Saldova Radka R   Hecht Elizabeth S ES   Muddiman David C DC   Kang Jichao J   Bhoskar Prachi P   Menard Daniele D   Saati Andrew A   Merle Christine C   Mast Steven S   Tep Sam S   Truong Jennie J   Nishikaze Takashi T   Sekiya Sadanori S   Shafer Aaron A   Funaoka Sohei S   Toyoda Masaaki M   de Vreugd Peter P   Caron Cassie C   Pradhan Pralima P   Tan Niclas Chiang NC   Mechref Yehia Y   Patil Sachin S   Rohrer Jeffrey S JS   Chakrabarti Ranjan R   Dadke Disha D   Lahori Mohammedazam M   Zou Chunxia C   Cairo Christopher C   Reiz Béla B   Whittal Randy M RM   Lebrilla Carlito B CB   Wu Lauren L   Guttman Andras A   Szigeti Marton M   Kremkow Benjamin G BG   Lee Kelvin H KH   Sihlbom Carina C   Adamczyk Barbara B   Jin Chunsheng C   Karlsson Niclas G NG   Örnros Jessica J   Larson Göran G   Nilsson Jonas J   Meyer Bernd B   Wiegandt Alena A   Komatsu Emy E   Perreault Helene H   Bodnar Edward D ED   Said Nassur N   Francois Yannis-Nicolas YN   Leize-Wagner Emmanuelle E   Maier Sandra S   Zeck Anne A   Heck Albert J R AJR   Yang Yang Y   Haselberg Rob R   Yu Ying Qing YQ   Alley William W   Leone Joseph W JW   Yuan Hua H   Stein Stephen E SE  

Molecular & cellular proteomics : MCP 20191007 1


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  ...[more]

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