Institute of Computing Technology, Chinese Academy IR
| NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods | |
| De Leoz, Maria Lorna A.1,86; Duewer, David L.2; Fung, Adam3; Liu, Lily3; Yau, Hoi Kei3; Potter, Oscar4; Staples, Gregory O.4; Furuki, Kenichiro5; Frenkel, Ruth6; Hu, Yunli6; Sosic, Zoran6; Zhang, Peiqing7; Altmann, Friedrich8; Grunwald-Grube, Clemens8; Shao, Chun9; Zaia, Joseph9; Evers, Waltraud10; Pengelley, Stuart10; Suckau, Detlev10; Wiechmann, Anja10; Resemann, Anja10; Jabs, Wolfgang10,11; Beck, Alain12; Froehlich, John W.13; Huang, Chuncui14; Li, Yan14; Liu, Yaming14; Sun, Shiwei15; Wang, Yaojun15; Seo, Youngsuk16; An, Hyun Joo16; Reichardt, Niels-Christian17; Ruiz, Juan Echevarria17,87; Archer-Hartmann, Stephanie18; Azadi, Parastoo18; Bell, Len19; Lakos, Zsuzsanna20; An, Yanming21; Cipollo, John F.21; Pucic-Bakovic, Maja22; Stambuk, Jerko22; Lauc, Gordan22,23; Li, Xu24; Wang, Peng George24; Bock, Andreas25; Hennig, Rene25; Rapp, Erdmann25,41; Creskey, Marybeth26; Cyr, Terry D.26; Nakano, Miyako27; Sugiyama, Taiki27; Leung, Pui-King Amy28; Link-Lenczowski, Pawe29; Jaworek, Jolanta29; Yang, Shuang30; Zhang, Hui30; Kelly, Tim31; Klapoetke, Song31; Cao, Rui31,88; Kim, Jin Young32; Lee, Hyun Kyoung32; Lee, Ju Yeon32; Yoo, Jong Shin32; Kim, Sa-Rang33; Suh, Soo-Kyung33; de Haan, Noortje34; Falck, David34; Lageveen-Kammeijer, Guinevere S. M.34; Wuhrer, Manfred34; Emery, Robert J.35; Kozak, Radoslaw P.35; Liew, Li Phing35; Royle, Louise35; Urbanowicz, Paulina A.35; Packer, Nicolle H.36,37; Song, Xiaomin36,37; Everest-Dass, Arun36,37,89; Lattova, Erika38; Cajic, Samanta39; Alagesan, Kathirvel40,90; Kolarich, Daniel40; Kasali, Toyin41; Lindo, Viv41; Chen, Yuetian42; Goswami, Kudrat42; Gau, Brian43,91; Amunugama, Ravi44; Jones, Richard44; Stroop, Corn J. M.45; Kato, Koichi46,47; Yagi, Hirokazu47; Kondo, Sachiko47,48; Yuen, C. T.49; Harazono, Akira50; Shi, Xiaofeng51; Magnelli, Paula E.51; Kasper, Brian T.52; Mahal, Lara52,92; Harvey, David J.53; O'Flaherty, Roisin54; Rudd, Pauline M.54; Saldova, Radka54; Hecht, Elizabeth S.55; Muddiman, David C.55; Kang, Jichao56; Bhoskar, Prachi57; Menard, Daniele57; Saati, Andrew57; Merle, Christine58; Mast, Steven59; Tep, Sam59; Truong, Jennie59; Nishikaze, Takashi60; Sekiya, Sadanori60; Shafer, Aaron61; Funaoka, Sohei62; Toyoda, Masaaki62; de Vreugd, Peter63; Caron, Cassie64; Pradhan, Pralima64; Tan, Niclas Chiang64; Mechref, Yehia65; Patil, Sachin66; Rohrer, Jeffrey S.66; Chakrabarti, Ranjan67; Dadke, Disha67,93; Lahori, Mohammedazam67,94; Zou, Chunxia68,69; Cairo, Christopher68,69; Reiz, Bela69; Whittal, Randy M.69; Lebrilla, Carlito B.70; Wu, Lauren70; Guttman, Andras71; Szigeti, Marton71,72; Kremkow, Benjamin G.73; Lee, Kelvin H.73; Sihlbom, Carina74; Adamczyk, Barbara75; Jin, Chunsheng75; Karlsson, Niclas G.75; Ornros, Jessica75; Larson, Gran76; Nilsson, Jonas76; Meyer, Bernd77; Wiegandt, Alena77; Komatsu, Emy78; Perreault, Helene78; Bodnar, Edward D.4,78; Said, Nassur79; Francois, Yannis-Nicolas79; Leize-Wagner, Emmanuelle79; Maier, Sandra80; Zeck, Anne80; Heck, Albert J. R.81,82; Yang, Yang81,82,95; Haselberg, Rob83; Yu, Ying Qing84; Alley, William84,96; Leone, Joseph W.85; Yuan, Hua85; Stein, Stephen E.1 | |
| 2020 | |
| 发表期刊 | MOLECULAR & CELLULAR PROTEOMICS
 |
| ISSN | 1535-9476 |
| 卷号 | 19期号:1页码:11-30 |
| 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. |
| 关键词 | Glycomics mass spectrometry fluorescence glycosylation glycoproteins glycan glycopeptide interlaboratory study NISTmAb reference antibody |
| DOI | 10.1074/mcp.RA119.001677 |
| 收录类别 | SCI |
| 语种 | 英语 |
| 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 |
| WOS类目 | Biochemical Research Methods |
| WOS记录号 | WOS:000518794300002 |
| 出版者 | AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC |
| 引用统计 | |
| 文献类型 | 期刊论文 |
| 条目标识符 | http://119.78.100.204/handle/2XEOYT63/14338 |
| 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.NIST, Mass Spectrometry Data Ctr, Biomol Measurement Div, Mat Measurement Lab, 100 Bur Dr, Gaithersburg, MD 20899 USA 2.NIST, Chem Sci Div, Mat Measurement Lab, 100 Bur Dr, Gaithersburg, MD 20899 USA 3.Agensys Inc, Analyt Dev, 1800 Steward St, Santa Monica, CA 90404 USA 4.Agilent Technol, 5301 Stevens Creek Blvd, Santa Clara, CA 95051 USA 5.Astellas Pharma, 5-2-3 Tokodai, Ibaraki 3002698, Japan 6.Biogen, Analyt Dev, Cambridge Ctr 14, Cambridge, MA 02142 USA 7.Bioproc Technol Inst, 20 Biopolis Way,Level 3, Singapore 138668, Singapore 8.Univ Nat Resources & Life Sci BOKU, Dept Chem, Muthgasse 18, A-1190 Vienna, Austria 9.Boston Univ, Sch Med, Ctr Biomed Mass Spectrometry, 670 Albany St, Boston, MA 02118 USA 10.Bruker Daltonik GmbH, Fahrenheit Str 4, D-28359 Bremen, Germany 11.Beuth Hsch Tech Berlin, Dept Life Sci & Technol, Seestr 64, D-13347 Berlin, Germany 12.Ctr Immunol Pierre Fabre, 5 Ave Napoleon 3,BP 60497, F-74164 St Julien En Genevois, France 13.Boston Childrens Hosp, Dept Urol, 300 Longwood Ave, Boston, MA 02115 USA 14.Chinese Acad Sci, Inst Biophys, 15 Da Tun Rd, Beijing 100101, Peoples R China 15.Chinese Acad Sci, Inst Comp Technol, Key Lab Intelligent Informat Proc, 15 Da Tun Rd, Beijing 100101, Peoples R China 16.Chungnam Natl Univ, Grad Sch Analyt Sci & Technol, Gung Dong 220, Daejeon 305764, South Korea 17.CICbiomaGUNE, Paseo Miramon 182, San Sebastian 20009, Spain 18.Univ Georgia, Complex Carbohydrate Res Ctr, Analyt Serv, 315 Riverbend Rd, Athens, GA 30602 USA 19.Covance Labs Ltd, BioCMC Solut Large Mol, Otley Rd, Harrogate HG3 1PY, N Yorkshire, England 20.Eurofins Lancaster Labs Inc, Biochem Method Dev & Validat, 2425 New Holland Pike, Lancaster, PA 17601 USA 21.US FDA, Ctr Biol Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA 22.Genos, Glycosci Res Lab, Borongajska Cesta 83h, Zagreb 10000, Croatia 23.Univ Zagreb, Fac Pharm & Biochem, A Kovacica 1, Zagreb 10000, Croatia 24.Georgia State Univ, Dept Chem, 100 Piedmont Ave, Atlanta, GA 30303 USA 25.glyXera GmbH, Brenneckestr 20 ZENIT, D-39120 Magdeburg, Germany 26.Hlth Canada, Hlth Prod & Foods Branch, 2201E,251 Sir Frederick Banting Driveway, Ottawa, ON K1A 0K9, Canada 27.Hiroshima Univ, Grad Sch Adv Sci Matter, 1-3-1 Kagamiyama, Higashihiroshima 7398530, Japan 28.ImmunoGen, 830 Winter St, Waltham, MA 02451 USA 29.Jagiellonian Univ, Coll Med, Dept Med Physiol, Ul Michalowskiego 12, PL-31126 Krakow, Poland 30.Johns Hopkins Univ, Dept Pathol, 400 N Broadway St, Baltimore, MD 21287 USA 31.KBI Biopharma, Mass Spec Core Facil, 1101 Hamlin Rd, Durham, NC 27704 USA 32.Korea Basic Sci Inst, Div Mass Spectrometry, 162 YeonGuDanji Ro, Cheongju Chungbuk 363883, South Korea 33.Korea Natl Inst Food & Drug Safety, Adv Therapy Prod Res Div, 187 Osongsaengmyeong 2 Ro, Cheongju 363700, Chungcheongbuk, South Korea 34.Leiden Univ, Med Ctr, Ctr Prote & Metabol, POB 9600, NL-2300 RC Leiden, Netherlands 35.Ludger Ltd, Culham Sci Ctr, Abingdon OX14 3EB, Oxon, England 36.Macquarie Univ, Biomol Discovery & Design Res Ctr, N Ryde, NSW, Australia 37.Macquarie Univ, ARC Ctr Excellence Nanoscale BioPhoton CNBP, N Ryde, NSW, Australia 38.Masaryk Univ, Cent European Inst Technol, Prote, Kamenice 5,A26, Brno 62500, Czech Republic 39.Max Planck Inst Dynam Complex Tech Syst, Sandtorstr 1, D-39106 Magdeburg, Germany 40.Max Planck Inst Colloids & Interfaces, Dept Biomol Sci, D-14424 Potsdam, Germany 41.AstraZeneca, Granta Pk CB21 6GH, Cambs, England 42.Merck, 2015 Galloping Hill Rd, Kenilworth, NJ 07033 USA 43.MilliporeSigma, Analyt R&D, 2909 Laclede Ave, St Louis, MO 63103 USA 44.MS Bioworks LLC, 3950 Varsity Dr, Ann Arbor, MI 48108 USA 45.MSD, Molenstr 110, NL-5342 CC Oss, Netherlands 46.Natl Inst Nat Sci, Exploratory Res Ctr Life & Living Syst ExCELLS, 5-1 Higashiyama, Okazaki, Aichi 4448787, Japan 47.Nagoya City Univ, Grad Sch Pharmaceut Sci, Mizuho Ku, 3-1 Tanabe Dori, Nagoya, Aichi 4678603, Japan 48.Med & Biol Labs Co Ltd, Chikusa Ku, 2-22-8 Chikusa, Nagoya, Aichi 4640858, Japan 49.Natl Inst Biol Stand & Controls, Blanche Lane, Potters Bar EN6 3QG, Herts, England 50.Natl Inst Hlth Sci, Div Biol Chem & Biol, Setagaya Ku, 1-18-1 Kamiyoga, Tokyo 1588501, Japan 51.New England Biolabs Inc, 240 Cty Rd, Ipswich, MA 01938 USA 52.NYU, 100 Washington Sq East, New York, NY 10003 USA 53.Univ Oxford, Target Discovery Inst, Nuffield Dept Med, Roosevelt Dr, Oxford OX3 7FZ, England 54.Natl Inst Bioproc Res & Training, GlycoSci Grp, Fosters Ave, Blackrock, Dublin, Ireland 55.North Carolina State Univ, Dept Chem, 2620 Yarborough Dr, Raleigh, NC 27695 USA 56.Pantheon, 201 Coll Rd East, Princeton, NJ 08540 USA 57.Pfizer Inc, 1 Burtt Rd, Andover, MA 01810 USA 58.Proteodynamics, ZI La Varenne 20-22 Rrue Henri & Gilberte Goudier, F-63200 Riom, France 59.ProZyme Inc, 3832 Bay Ctr Pl, Hayward, CA 94545 USA 60.Shimadzu Co Ltd, Koichi Tanaka Mass Spectrometry Res Lab, Nakagyo Ku, 1 Nishinokyo Kuwabara Cho, Kyoto 6048511, Japan 61.Childrens GMP LLC, St Jude Childrens Res Hosp, 262 Danny Thomas Pl, Memphis, TN 38105 USA 62.Sumitomo Bakelite Co Ltd, Nishi Ku, 1-5 Muromati 1 Chome, Kobe, Hyogo 6512241, Japan 63.Synthon Biopharmaceut, Microweg 22,POB 7071, NL-6503 GN Nijmegen, Netherlands 64.Takeda Pharmaceut Int Co, 40 Landsdowne St, Cambridge, MA 02139 USA 65.Texas Tech Univ, Dept Chem & Biochem, 2500 Broadway, Lubbock, TX 79409 USA 66.Thermo Fisher Sci, 1214 Oakmead Pkwy, Sunnyvale, CA 94085 USA 67.US Pharmacopeia India Pvt Ltd, IKP Knowledge Pk, Hyderabad 500101, Telangana, India 68.Univ Alberta, Alberta Glyc Ctr, Edmonton, AB T6G 2G2, Canada 69.Univ Alberta, Dept Chem, Edmonton, AB T6G 2G2, Canada 70.Univ Calif Davis, Dept Chem, One Shields Ave, Davis, CA 95616 USA 71.Univ Debrecen, Doctoral Sch Mol Med, Fac Med, Horvath Csaba Mem Lab Bioseparat Sci,Res Ctr Mol, Egyet Ter 1, Debrecen, Hungary 72.Univ Pannonia, Res Inst Biomol & Chem Engn, Translat Glyc Res Grp, Egyet Ut 10, Veszprem, Hungary 73.Univ Delaware, Delaware Biotechnol Inst, 15 Innovat Way, Delaware, OH 19711 USA 74.Univ Gothenburg, Prote Core Facil, Medicinaregatan 1G, SE-41390 Gothenburg, Sweden 75.Univ Gothenburg, Sahlgrenska Acad, Inst Biomed, Dept Med Biochem & Cell Biol, Medicinaregatan 9A,Box 440, S-40530 Gothenburg, Sweden 76.Univ Gothenburg, Sahlgrenska Acad, Dept Clin Chem & Transfus Med, Bruna Straket 16, S-41345 Gothenburg, Sweden 77.Univ Hamburg, Dept Chem, Martin Luther King Pl 6, D-20146 Hamburg, Germany 78.Univ Manitoba, Dept Chem, 144 Dysart Rd, Winnipeg, MB R3T 2N2, Canada 79.Univ Strasbourg, UMR Unistra CNRS 7140, Lab Mass Spectrometry Interact & Syst, Strasbourg, France 80.Univ T bingen, Nat & Med Sci Inst, Markwiesenstr 55, D-72770 Reutlingen, Germany 81.Univ Utrecht, Bijvoet Ctr Biomol Res, Padualaan 8, NL-3584 CH Utrecht, Netherlands 82.Univ Utrecht, Utrecht Inst Pharmaceut Sci, Padualaan 8, NL-3584 CH Utrecht, Netherlands 83.Vrije Univ Amsterdam, Amsterdam Inst Mol Med & Syst, Div Bioanalyt Chem, de Boelelaan 1085, Amsterdam, Netherlands 84.Waters Corp, Dept Chem, 34 Maple St, Milford, MA 01757 USA 85.Zoetis, 333 Portage St, Kalamazoo, MI 49007 USA 86.Agilent Technol, 2500 Regency Pkwy, Cary, NC 27518 USA 87.Asparia Glyc, San Sebastian 8320009, Spain 88.Janssen R&D LLC, Analyt Dev Prot Characterizat, 260 Great Valley, Malvern, PA 19355 USA 89.Griffith Univ, Inst Glyc, Southport, Qld, Australia 90.Griffith Univ, Inst Glyc, Gold Coast Campus, Nathan, Qld 4222, Australia 91.Pfizer, 700 Chesterfield Pkwy W, St Louis, MO 63198 USA 92.Univ Alberta, Dept Chem, 11227 Saskatchewan Dr, Edmonton, AB T6G 2G2, Canada 93.Aurobindo Biol, Analyt Regulatory & Clin Sci, Hyderabad 502329, Telangana, India 94.Intas Pharmaceut Ltd, Translat Sci, 423-P-A,Sarkhej Bavla Highway, Ahmadabad 382213, Gujarat, India 95.Inc Novartis Pharma, Novartis Inst BioMed Res, Novartis Biol Ctr, CH-4002 Basel, Switzerland 96.Texas A&M Univ, Dept Sci & Math, One Univ Way, San Antonio, TX 78224 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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