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Chinese Academy of Sciences Institutional Repositories Grid
NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods

文献类型:期刊论文

作者De Leoz, Maria Lorna A.2,88; Duewer, David L.3; Fung, Adam4; Liu, Lily4; Yau, Hoi Kei4; Potter, Oscar5; Staples, Gregory O.5; Furuki, Kenichiro6; Frenkel, Ruth7; Hu, Yunli7
刊名MOLECULAR & CELLULAR PROTEOMICS
出版日期2020
卷号19期号:1页码:11-30
ISSN号1535-9476
关键词Glycomics mass spectrometry fluorescence glycosylation glycoproteins glycan glycopeptide interlaboratory study NISTmAb reference antibody
DOI10.1074/mcp.RA119.001677
英文摘要A broad-based interlaboratory study of glycosylation profiles of a reference and modified IgG antibody involving 103 reports from 76 laboratories. 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.
资助项目Science Foundation Ireland Starting Investigator Research[13/SIRG/2164] ; Swedish Research Council[8266] ; Swedish Research Council[621-2013-5895] ; Alberta Glycomics Centre ; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)[K01-DK101632] ; Australian Research Council Centre of Excellence for Nanoscale BioPhotonics (CNBP)[CE1401000003] ; European Union (EU) FP7 program HighGlycan[278535] ; National Institutes of Health (NIH) Research Resource for Biomedical Glycomics[P41GM10349010] ; National Institutes of Health (NIH) Research Resource for Biomedical Glycomics[1S10OD018530] ; Austrian Research Promotion Agency Laura Bassi Center of Expertise[822757] ; National Natural Science Foundation of China[31600650] ; National Natural Science Foundation of China[31671369] ; National Natural Science Foundation of China[31770775D] ; Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) The concert of dolichol-based glycosylation: from molecules to disease models[FOR2509] ; European Union (EC) IMforFuture[721815] ; German Federal Ministry of Education and Research (BMBF) Die Golgi Glykan Fabrik 2.0[031A557] ; Health Canada, Government of Canada ; European Union FP7 GastricGlycoExplorer ITN[316929] ; National Research Council of Science and Technology Creative Allied Project (CAP)[NTM2371511] ; Hungarian Government project[NKFIH-K 116263] ; Hungarian Government project[BIONANO GINOP-2.3.2-15-2016-00017] ; National Research Foundation of Korea[NRF-2013M3A9B6075933]
WOS研究方向Biochemistry & Molecular Biology
语种英语
出版者AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
WOS记录号WOS:000518794300002
源URL[http://119.78.100.204/handle/2XEOYT63/14337]  
专题中国科学院计算技术研究所期刊论文_英文
通讯作者De Leoz, Maria Lorna A.
作者单位1.Beuth Hsch Tech Berlin, Dept Life Sci & Technol, Seestr 64, D-13347 Berlin, Germany
2.NIST, Mass Spectrometry Data Ctr, Biomol Measurement Div, Mat Measurement Lab, 100 Bur Dr, Gaithersburg, MD 20899 USA
3.NIST, Chem Sci Div, Mat Measurement Lab, 100 Bur Dr, Gaithersburg, MD 20899 USA
4.Agensys Inc, Analyt Dev, 1800 Steward St, Santa Monica, CA 90404 USA
5.Agilent Technol, 5301 Stevens Creek Blvd, Santa Clara, CA 95051 USA
6.Astellas Pharma, 5-2-3 Tokodai, Ibaraki 3002698, Japan
7.Biogen, Analyt Dev, Cambridge Ctr 14, Cambridge, MA 02142 USA
8.Bioproc Technol Inst, 20 Biopolis Way,Level 3, Singapore 138668, Singapore
9.Univ Nat Resources & Life Sci BOKU, Dept Chem, Muthgasse 18, A-1190 Vienna, Austria
10.Boston Univ, Sch Med, Ctr Biomed Mass Spectrometry, 670 Albany St, Boston, MA 02118 USA
推荐引用方式
GB/T 7714
De Leoz, Maria Lorna A.,Duewer, David L.,Fung, Adam,et al. NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods[J]. MOLECULAR & CELLULAR PROTEOMICS,2020,19(1):11-30.
APA De Leoz, Maria Lorna A..,Duewer, David L..,Fung, Adam.,Liu, Lily.,Yau, Hoi Kei.,...&Stein, Stephen E..(2020).NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods.MOLECULAR & CELLULAR PROTEOMICS,19(1),11-30.
MLA De Leoz, Maria Lorna A.,et al."NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods".MOLECULAR & CELLULAR PROTEOMICS 19.1(2020):11-30.

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来源:计算技术研究所

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