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NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods
MLA. De Leoz, DL. Duewer, A. Fung, L. Liu, HK. Yau, O. Potter, GO. Staples, K. Furuki, R. Frenkel, Y. Hu, Z. Sosic, P. Zhang, F. Altmann, C. Gru Nwald-Grube, C. Shao, J. Zaia, W. Evers, S. Pengelley, D. Suckau, A. Wiechmann, A. Resemann, W. Jabs,...
Molecular and cellular proteomics.
2020 ;
19 (1) :
11-30.
[pub] 20191007
Language English Country United States
Document type Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
Persistent link
https://www.medvik.cz/link/bmc20028659
Grant support
K01 DK101632
NIDDK NIH HHS - United States
R01 GM112490
NIGMS NIH HHS - United States
R01 GM130091
NIGMS NIH HHS - United States
S10 OD018530
NIH HHS - United States
Online
Full text
NLK
Free Medical Journals
from 2002 to 1 year ago
Freely Accessible Science Journals
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PubMed Central
from 2008
Europe PubMed Central
from 2008 to 1 year ago
Open Access Digital Library
from 2002-01-01
ROAD: Directory of Open Access Scholarly Resources
from 2002
- MeSH
- Biopharmaceutics methods MeSH
- Biological Products * MeSH
- Glycomics methods MeSH
- Glycopeptides metabolism MeSH
- Glycosylation MeSH
- Laboratories MeSH
- Humans MeSH
- Antibodies, Monoclonal chemistry metabolism MeSH
- Polysaccharides metabolism MeSH
- Protein Processing, Post-Translational MeSH
- Proteomics methods MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Research Support, N.I.H., Extramural MeSH
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.
Agilent Technologies Inc 5301 Stevens Creek Blvd Santa Clara California 95051
Analytical Development Agensys Inc 1800 Steward Street Santa Monica California 90404
Analytical Development Biogen 14 Cambridge Center Cambridge Massachusetts 02142
Analytical R and D MilliporeSigma 2909 Laclede Ave St Louis Missouri 63103
Astellas Pharma 5 2 3 Tokodai Tsukiba Ibaraki 300 2698 Japan
AstraZeneca Granta Park Cambridgeshire CB21 6GH United Kingdom
Bioprocessing Technology Institute 20 Biopolis Way Level 3 Singapore 138668
Bruker Daltonik GmbH Fahrenheitstr 4 28359 Bremen Germany
Centre d'Immunologie Pierre Fabre 5 Avenue Napoléon 3 BP 60497 74164 St Julien en Genevois France
CICbiomaGUNE Paseo Miramon 182 20009 San Sebastian Spain
Delaware Biotechnology Institute University of Delaware 15 Innovation Way Newark Delaware 19711
Department of Chemistry and Biochemistry Texas Tech University 2500 Broadway Lubbock Texas 79409
Department of Chemistry Georgia State University 100 Piedmont Avenue Atlanta Georgia 30303
Department of Chemistry University of Alberta Edmonton Alberta T6G 2G2 Canada
Department of Chemistry University of California One Shields Ave Davis California 95616
Department of Chemistry University of Hamburg Martin Luther King Pl 6 20146 Hamburg Germany
Department of Chemistry University of Manitoba 144 Dysart Road Winnipeg Manitoba Canada R3T 2N2
Department of Chemistry Waters Corporation 34 Maple Street Milford Massachusetts 01757
Department of Pathology Johns Hopkins University 400 N Broadway Street Baltimore Maryland 21287
Department of Urology Boston Children's Hospital 300 Longwood Avenue Boston Massachusetts 02115
Glycoscience Research Laboratory Genos Borongajska cesta 83h 10 000 Zagreb Croatia
glyXera GmbH Brenneckestrasse 20 * ZENIT 39120 Magdeburg Germany
ImmunoGen 830 Winter Street Waltham Massachusetts 02451
Ludger Limited Culham Science Centre Abingdon Oxfordshire OX14 3EB United Kingdom
Mass Spec Core Facility KBI Biopharma 1101 Hamlin Road Durham North Carolina 27704
Merck 2015 Galloping Hill Rd Kenilworth New Jersey 07033
MS Bioworks LLC 3950 Varsity Drive Ann Arbor Michigan 48108
MSD Molenstraat 110 5342 CC Oss The Netherlands
New England Biolabs Inc 240 County Road Ipswich Massachusetts 01938
New York University 100 Washington Square East New York City New York 10003
Pantheon 201 College Road East Princeton New Jersey 08540
Pfizer Inc 1 Burtt Road Andover Massachusetts 01810
Proteodynamics ZI La Varenne 20 22 rue Henri et Gilberte Goudier 63200 RIOM France
Proteomics Core Facility University of Gothenburg Medicinaregatan 1G SE 41390 Gothenburg Sweden
ProZyme Inc 3832 Bay Center Place Hayward California 94545
Sumitomo Bakelite Co Ltd 1 5 Muromati 1 Chome Nishiku Kobe 651 2241 Japan
Synthon Biopharmaceuticals Microweg 22 P O Box 7071 6503 GN Nijmegen The Netherlands
Takeda Pharmaceuticals International Co 40 Landsdowne Street Cambridge Massachusetts 02139
Thermo Fisher Scientific 1214 Oakmead Parkway Sunnyvale California 94085
References provided by Crossref.org
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- 700 1_
- $a O'Flaherty, Roisin $u GlycoScience Group, The National Institute for Bioprocessing Research and Training, Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland.
- 700 1_
- $a Rudd, Pauline M $u GlycoScience Group, The National Institute for Bioprocessing Research and Training, Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland.
- 700 1_
- $a Saldova, Radka $u GlycoScience Group, The National Institute for Bioprocessing Research and Training, Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland.
- 700 1_
- $a Hecht, Elizabeth S $u Department of Chemistry, North Carolina State University, 2620 Yarborough Drive Raleigh, North Carolina 27695.
- 700 1_
- $a Muddiman, David C $u Department of Chemistry, North Carolina State University, 2620 Yarborough Drive Raleigh, North Carolina 27695.
- 700 1_
- $a Kang, Jichao $u Pantheon, 201 College Road East Princeton, New Jersey 08540.
- 700 1_
- $a Bhoskar, Prachi $u Pfizer Inc., 1 Burtt Road Andover, Massachusetts 01810.
- 700 1_
- $a Menard, Daniele $u Pfizer Inc., 1 Burtt Road Andover, Massachusetts 01810.
- 700 1_
- $a Saati, Andrew $u Pfizer Inc., 1 Burtt Road Andover, Massachusetts 01810.
- 700 1_
- $a Merle, Christine $u Proteodynamics, ZI La Varenne 20-22 rue Henri et Gilberte Goudier 63200 RIOM, France.
- 700 1_
- $a Mast, Steven $u ProZyme, Inc., 3832 Bay Center Place Hayward, California 94545.
- 700 1_
- $a Tep, Sam $u ProZyme, Inc., 3832 Bay Center Place Hayward, California 94545.
- 700 1_
- $a Truong, Jennie $u ProZyme, Inc., 3832 Bay Center Place Hayward, California 94545.
- 700 1_
- $a Nishikaze, Takashi $u Koichi Tanaka Mass Spectrometry Research Laboratory, Shimadzu Corporation, 1 Nishinokyo Kuwabara-cho Nakagyo-ku, Kyoto, 604 8511 Japan.
- 700 1_
- $a Sekiya, Sadanori $u Koichi Tanaka Mass Spectrometry Research Laboratory, Shimadzu Corporation, 1 Nishinokyo Kuwabara-cho Nakagyo-ku, Kyoto, 604 8511 Japan.
- 700 1_
- $a Shafer, Aaron $u Children's GMP LLC, St. Jude Children's Research Hospital, 262 Danny Thomas Place Memphis, Tennessee 38105.
- 700 1_
- $a Funaoka, Sohei $u Sumitomo Bakelite Co., Ltd., 1-5 Muromati 1-Chome, Nishiku, Kobe, 651-2241 Japan.
- 700 1_
- $a Toyoda, Masaaki $u Sumitomo Bakelite Co., Ltd., 1-5 Muromati 1-Chome, Nishiku, Kobe, 651-2241 Japan.
- 700 1_
- $a de Vreugd, Peter $u Synthon Biopharmaceuticals, Microweg 22 P.O. Box 7071, 6503 GN Nijmegen, The Netherlands.
- 700 1_
- $a Caron, Cassie $u Takeda Pharmaceuticals International Co., 40 Landsdowne Street Cambridge, Massachusetts 02139.
- 700 1_
- $a Pradhan, Pralima $u Takeda Pharmaceuticals International Co., 40 Landsdowne Street Cambridge, Massachusetts 02139.
- 700 1_
- $a Tan, Niclas Chiang $u Takeda Pharmaceuticals International Co., 40 Landsdowne Street Cambridge, Massachusetts 02139.
- 700 1_
- $a Mechref, Yehia $u Department of Chemistry and Biochemistry, Texas Tech University, 2500 Broadway, Lubbock, Texas 79409.
- 700 1_
- $a Patil, Sachin $u Thermo Fisher Scientific, 1214 Oakmead Parkway Sunnyvale, California 94085.
- 700 1_
- $a Rohrer, Jeffrey S $u Thermo Fisher Scientific, 1214 Oakmead Parkway Sunnyvale, California 94085.
- 700 1_
- $a Chakrabarti, Ranjan $u United States Pharmacopeia India Pvt. Ltd. IKP Knowledge Park, Genome Valley, Shamirpet, Turkapally Village, Medchal District, Hyderabad 500 101 Telangana, India.
- 700 1_
- $a Dadke, Disha $u United States Pharmacopeia India Pvt. Ltd. IKP Knowledge Park, Genome Valley, Shamirpet, Turkapally Village, Medchal District, Hyderabad 500 101 Telangana, India.
- 700 1_
- $a Lahori, Mohammedazam $u United States Pharmacopeia India Pvt. Ltd. IKP Knowledge Park, Genome Valley, Shamirpet, Turkapally Village, Medchal District, Hyderabad 500 101 Telangana, India.
- 700 1_
- $a Zou, Chunxia $u Alberta Glycomics Centre, University of Alberta, Edmonton, Alberta T6G 2G2 Canada. Department of Chemistry, University of Alberta, Edmonton, Alberta T6G 2G2 Canada.
- 700 1_
- $a Cairo, Christopher $u Alberta Glycomics Centre, University of Alberta, Edmonton, Alberta T6G 2G2 Canada. Department of Chemistry, University of Alberta, Edmonton, Alberta T6G 2G2 Canada.
- 700 1_
- $a Reiz, Béla $u Department of Chemistry, University of Alberta, Edmonton, Alberta T6G 2G2 Canada.
- 700 1_
- $a Whittal, Randy M $u Department of Chemistry, University of Alberta, Edmonton, Alberta T6G 2G2 Canada.
- 700 1_
- $a Lebrilla, Carlito B $u Department of Chemistry, University of California, One Shields Ave, Davis, California 95616.
- 700 1_
- $a Wu, Lauren $u Department of Chemistry, University of California, One Shields Ave, Davis, California 95616.
- 700 1_
- $a Guttman, Andras $u Horváth Csaba Memorial Laboratory for Bioseparation Sciences, Research Center for Molecular Medicine, Doctoral School of Molecular Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Egyetem ter 1, Hungary.
- 700 1_
- $a Szigeti, Marton $u Horváth Csaba Memorial Laboratory for Bioseparation Sciences, Research Center for Molecular Medicine, Doctoral School of Molecular Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Egyetem ter 1, Hungary. Translational Glycomics Research Group, Research Institute of Biomolecular and Chemical Engineering, University of Pannonia, Veszprem, Egyetem ut 10, Hungary.
- 700 1_
- $a Kremkow, Benjamin G $u Delaware Biotechnology Institute, University of Delaware, 15 Innovation Way Newark, Delaware 19711.
- 700 1_
- $a Lee, Kelvin H $u Delaware Biotechnology Institute, University of Delaware, 15 Innovation Way Newark, Delaware 19711.
- 700 1_
- $a Sihlbom, Carina $u Proteomics Core Facility, University of Gothenburg, Medicinaregatan 1G SE 41390 Gothenburg, Sweden.
- 700 1_
- $a Adamczyk, Barbara $u Department of Medical Biochemistry and Cell Biology, University of Gothenburg, Institute of Biomedicine, Sahlgrenska Academy, Medicinaregatan 9A, Box 440, 405 30, Gothenburg, Sweden.
- 700 1_
- $a Jin, Chunsheng $u Department of Medical Biochemistry and Cell Biology, University of Gothenburg, Institute of Biomedicine, Sahlgrenska Academy, Medicinaregatan 9A, Box 440, 405 30, Gothenburg, Sweden.
- 700 1_
- $a Karlsson, Niclas G $u Department of Medical Biochemistry and Cell Biology, University of Gothenburg, Institute of Biomedicine, Sahlgrenska Academy, Medicinaregatan 9A, Box 440, 405 30, Gothenburg, Sweden.
- 700 1_
- $a Örnros, Jessica $u Department of Medical Biochemistry and Cell Biology, University of Gothenburg, Institute of Biomedicine, Sahlgrenska Academy, Medicinaregatan 9A, Box 440, 405 30, Gothenburg, Sweden.
- 700 1_
- $a Larson, Göran $u Department of Clinical Chemistry and Transfusion Medicine, Sahlgrenska Academy at the University of Gothenburg, Bruna Straket 16, 41345 Gothenburg, Sweden.
- 700 1_
- $a Nilsson, Jonas $u Department of Clinical Chemistry and Transfusion Medicine, Sahlgrenska Academy at the University of Gothenburg, Bruna Straket 16, 41345 Gothenburg, Sweden.
- 700 1_
- $a Meyer, Bernd $u Department of Chemistry, University of Hamburg, Martin Luther King Pl. 6 20146 Hamburg, Germany.
- 700 1_
- $a Wiegandt, Alena $u Department of Chemistry, University of Hamburg, Martin Luther King Pl. 6 20146 Hamburg, Germany.
- 700 1_
- $a Komatsu, Emy $u Department of Chemistry, University of Manitoba, 144 Dysart Road, Winnipeg, Manitoba, Canada R3T 2N2.
- 700 1_
- $a Perreault, Helene $u Department of Chemistry, University of Manitoba, 144 Dysart Road, Winnipeg, Manitoba, Canada R3T 2N2.
- 700 1_
- $a Bodnar, Edward D $u Department of Chemistry, University of Manitoba, 144 Dysart Road, Winnipeg, Manitoba, Canada R3T 2N2. Agilent Technologies, Inc., 5301 Stevens Creek Blvd Santa Clara, California 95051.
- 700 1_
- $a Said, Nassur $u Laboratory of Mass Spectrometry of Interactions and Systems, University of Strasbourg, UMR Unistra-CNRS 7140, France.
- 700 1_
- $a Francois, Yannis-Nicolas $u Laboratory of Mass Spectrometry of Interactions and Systems, University of Strasbourg, UMR Unistra-CNRS 7140, France.
- 700 1_
- $a Leize-Wagner, Emmanuelle $u Laboratory of Mass Spectrometry of Interactions and Systems, University of Strasbourg, UMR Unistra-CNRS 7140, France.
- 700 1_
- $a Maier, Sandra $u Natural and Medical Sciences Institute, University of Tübingen, Markwiesenstraβe 55, 72770 Reutlingen, Germany.
- 700 1_
- $a Zeck, Anne $u Natural and Medical Sciences Institute, University of Tübingen, Markwiesenstraβe 55, 72770 Reutlingen, Germany.
- 700 1_
- $a Heck, Albert J R $u Bijvoet Center for Biomolecular Research and Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Padualaan 8, 3584 CH Utrecht, The Netherlands.
- 700 1_
- $a Yang, Yang $u Bijvoet Center for Biomolecular Research and Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Padualaan 8, 3584 CH Utrecht, The Netherlands.
- 700 1_
- $a Haselberg, Rob $u Division of Bioanalytical Chemistry, Amsterdam Institute for Molecules, Medicines and Systems, Vrije Universiteit Amsterdam, de Boelelaan 1085, 1081 HV Amsterdam, The Netherlands.
- 700 1_
- $a Yu, Ying Qing $u Department of Chemistry, Waters Corporation, 34 Maple Street Milford, Massachusetts 01757.
- 700 1_
- $a Alley, William $u Department of Chemistry, Waters Corporation, 34 Maple Street Milford, Massachusetts 01757.
- 700 1_
- $a Leone, Joseph W $u Zoetis, 333 Portage St. Kalamazoo, Michigan 49007.
- 700 1_
- $a Yuan, Hua $u Zoetis, 333 Portage St. Kalamazoo, Michigan 49007.
- 700 1_
- $a Stein, Stephen E $u Mass Spectrometry Data Center, Biomolecular Measurement Division, Material Measurement Laboratory, National Institute of Standards and Technology, 100 Bureau Drive Gaithersburg, Maryland 20899.
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