Interlaboratory Study for Characterizing Monoclonal Antibodies by Top-Down and Middle-Down Mass Spectrometry

Srzentić, Kristina; Fornelli, Luca; Tsybin, Yury O.; Loo, Joseph A.; Seckler, Henrique; Agar, Jeffrey N.; Anderson, Lissa C.; Bai, Dina L.; Beck, Alain; Brodbelt, Jennifer S.; van der Burgt, Yuri M.; Chamot-Rooke, Julia; Chatterjee, Sneha; Chen, Yunqiu; Clarke, David J.; Danis, Paul O.; Diedrich, Jolene K.; D’Ippolito, Robert A.; Dupré, Mathieu; Gasilova, Natalia; Ge, Ying; Goo, Young Ah; Goodlett, David R.; Greer, Sylvester; Haselmann, Kim F.; He, Lidong; Hendrickson, Christopher L.; Hinkle, Joshua D.; Holt, Matthew V.; Hughes, Sam; Hunt, Donald F.; Kelleher, Neil L.; Kozhinov, Anton N.; Lin, Ziqing; Malosse, Christian; Marshall, Alan G.; Menin, Laure; Millikin, Robert J.; Nagornov, Konstantin O.; Nicolardi, Simone; Paša-Tolić, Ljiljana; Pengelley, Stuart; Quebbemann, Neil R.; Resemann, Anja; Sandoval, Wendy; Sarin, Richa; Schmitt, Nicholas D.; Shabanowitz, Jeffrey; Shaw, Jared B.; Shortreed, Michael R.; Smith, Lloyd M.; Sobott, Frank; Suckau, Detlev; Toby, Timothy; Weisbrod, Chad R.; Wildburger, Norelle C.; Yates, John R.; Yoon, Sung Hwan; Young, Nicolas L.; Zhou, Mowei

doi:10.1021/jasms.0c00036

Title: Interlaboratory Study for Characterizing Monoclonal Antibodies by Top-Down and Middle-Down Mass Spectrometry

Journal Article · 30 July 2020 · Journal of the American Society for Mass Spectrometry

DOI: https://doi.org/10.1021/jasms.0c00036 · OSTI ID:1671041

Srzentić, Kristina ^[1]; Fornelli, Luca ^[1];

^[2];

^[3]; Seckler, Henrique ^[1]; Agar, Jeffrey N. ^[4];

^[5]; Bai, Dina L. ^[6];

^[7];

^[8];

^[9];

^[10]; Chatterjee, Sneha ^[11]; Chen, Yunqiu ^[12];

^[13]; Danis, Paul O. ^[14]; Diedrich, Jolene K. ^[15];

^[6];

^[10]; Gasilova, Natalia ^[16] more »

Northwestern University, Evanston, Illinois 60208-0001, United States
Spectroswiss, EPFL Innovation Park, Building I, 1015 Lausanne, Switzerland
University of California-Los Angeles, Los Angeles, California 90095, United States
Northeastern University, Boston, Massachusetts 02115, United States
National High Magnetic Field Laboratory, Tallahassee, Florida 32310, United States
University of Virginia, Charlottesville, Virginia 22901, United States
Centre d’immunologie Pierre Fabre, 74160 Saint-Julien-en-Genevois, France
University of Texas at Austin, Austin, Texas 78712-1224, United States
Leiden University Medical Centre, 2300 RC Leiden, The Netherlands
Institute Pasteur, 75015 Paris, France
University of Antwerp, 2000 Antwerp, Belgium
Biogen, Inc., Cambridge, Massachusetts 02142-1031, United States
The University of Edinburgh, EH9 3FJ Edinburgh, United Kingdom
Consortium for Top-Down Proteomics, Cambridge, Massachusetts 02142, United States
The Scripps Research Institute, La Jolla, California 92037, United States
Ecole Polytechnique Fédérale de Lausanne, 1015 Lausanne, Switzerland
University of Wisconsin-Madison, Madison, Wisconsin 53706, United States
University of Maryland, Baltimore, Maryland 21201, United States
Novo Nordisk, DK-2760 Malov, Denmark
Baylor College of Medicine, Houston, Texas 77030-3411, United States
National High Magnetic Field Laboratory, Tallahassee, Florida 32310, United States; Florida State University, Tallahassee, Florida 32310-4005, United States
Pacific Northwest National Laboratory, Richland, Washington 99354, United States
Bruker Daltonik GmbH, 28359 Bremen, Germany
Genentech, Inc., South San Francisco, California 94080-4990, United States
University of Antwerp, 2000 Antwerp, Belgium; University of Leeds, LS2 9JT Leeds, United Kingdom
Washington University School of Medicine, St. Louis, Missouri 63110, United States

The Consortium for Top-Down Proteomics (www.topdownproteomics.org) launched the present study to assess the state of top-down mass spectrometry (TD MS) and middle-down mass spectrometry (MD MS) for characterizing monoclonal antibody (mAb) primary structures, including their modifications. To meet the needs of the rapidly growing therapeutic antibody market, it is important to develop analytical strategies to characterize the heterogeneity of a therapeutic product’s primary structure reliably and reproducibly. The major objective of the present study was to determine whether current TD/MD MS technologies and protocols can add value to the more commonly employed bottom-up approaches, such as confirming protein integrity, sequencing variable domains, ruling out artefacts, and revealing modifications and their locations. A panel of three mAbs was selected and centrally provided to twenty laboratories worldwide for the analysis: Sigma mAb standard (SiLuLite), NIST mAb standard, and the therapeutic mAb Herceptin (trastuzumab). A variety of different MS instrument platforms and ion dissociation techniques were employed. Overall, the present study confirms that MD/TD MS strategies are valuable and readily available tools in laboratories worldwide. They provide complementary information to the bottom-up approach and can add unique information, which may be crucial for comprehensive mAb characterization. The current limitations, as well as possible solutions to overcome them, are also outlined. One of the limitations revealed by the results of the present study is that the expert knowledge in both experiment and data analysis is indispensable to practice TD/MD MS, but the number of TD/MD MS experts is still very low.

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Research Organization:: Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)

Sponsoring Organization:: USDOE

Contributing Organization:: The Consortium for Top-Down Proteomics

Grant/Contract Number:: AC05-76RL01830

OSTI ID:: 1671041

Report Number(s):: PNNL-SA-147397

Journal Information:: Journal of the American Society for Mass Spectrometry, Journal Name: Journal of the American Society for Mass Spectrometry Journal Issue: 9 Vol. 31; ISSN 1044-0305

Publisher:: American Society for Mass SpectrometryCopyright Statement

Country of Publication:: United States

Language:: English

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Structure, heterogeneity and developability assessment of therapeutic antibodies Xu, Yingda; Wang, Dongdong; Mason, Bruce mAbs, Vol. 11, Issue 2 https://doi.org/10.1080/19420862.2018.1553476	journal	December 2018
Characterization and prediction of positional 4-hydroxyproline and sulfotyrosine, two post-translational modifications that can occur at substantial levels in CHO cells-expressed biotherapeutics Tyshchuk, Oksana; Gstöttner, Christoph; Funk, Dennis mAbs, Vol. 11, Issue 7 https://doi.org/10.1080/19420862.2019.1635865	journal	July 2019
Monitoring glycation levels of a bispecific monoclonal antibody at subunit level by ultrahigh-resolution MALDI FT-ICR mass spectrometry Gstöttner, Christoph; Reusch, Dietmar; Haberger, Markus mAbs, Vol. 12, Issue 1 https://doi.org/10.1080/19420862.2019.1682403	journal	December 2019
Antibodies to watch in 2020 Kaplon, Hélène; Muralidharan, Mrinalini; Schneider, Zita mAbs, Vol. 12, Issue 1 https://doi.org/10.1080/19420862.2019.1703531	journal	December 2019
Top-down analysis of protein samples by de novo sequencing techniques Vyatkina, Kira; Wu, Si; Dekker, Lennard J. M. Bioinformatics, Vol. 32, Issue 18 https://doi.org/10.1093/bioinformatics/btw307	journal	May 2016
EndoS and EndoS2 hydrolyze Fc-glycans on therapeutic antibodies with different glycoform selectivity and can be used for rapid quantification of high-mannose glycans Sjögren, Jonathan; Cosgrave, Eoin F. J.; Allhorn, Maria Glycobiology, Vol. 25, Issue 10 https://doi.org/10.1093/glycob/cwv047	journal	July 2015
Top-down MS, a powerful complement to the high capabilities of proteolysis proteomics: Top-down MS of proteins McLafferty, Fred W.; Breuker, Kathrin; Jin, Mi FEBS Journal, Vol. 274, Issue 24 https://doi.org/10.1111/j.1742-4658.2007.06147.x	journal	November 2007
Extending Top-Down Mass Spectrometry to Proteins with Masses Greater Than 200 Kilodaltons Han, X.; Jin, M.; Breuker, K. Science, Vol. 314, Issue 5796 https://doi.org/10.1126/science.1128868	journal	October 2006
Primary sequence information from intact proteins by electrospray ionization tandem mass spectrometry Loo, J.; Edmonds, C.; Smith, R. Science, Vol. 248, Issue 4952 https://doi.org/10.1126/science.2326633	journal	April 1990
Progress in Top-Down Proteomics and the Analysis of Proteoforms Toby, Timothy K.; Fornelli, Luca; Kelleher, Neil L. Annual Review of Analytical Chemistry, Vol. 9, Issue 1 https://doi.org/10.1146/annurev-anchem-071015-041550	journal	June 2016
A View on the Importance of “Multi-Attribute Method” for Measuring Purity of Biopharmaceuticals and Improving Overall Control Strategy Rogers, Richard S.; Abernathy, Michael; Richardson, Douglas D. The AAPS Journal, Vol. 20, Issue 1 https://doi.org/10.1208/s12248-017-0168-3	journal	November 2017
Recent Advances and Ongoing Challenges in the Diagnosis of Microbial Infections by MALDI-TOF Mass Spectrometry Florio, Walter; Tavanti, Arianna; Barnini, Simona Frontiers in Microbiology, Vol. 9 https://doi.org/10.3389/fmicb.2018.01097	journal	May 2018
Macro- and Micro-Heterogeneity of Natural and Recombinant IgG Antibodies Beck, Alain; Liu, Hongcheng Antibodies, Vol. 8, Issue 1 https://doi.org/10.3390/antib8010018	journal	February 2019
Correct primary structure assessment and extensive glyco-profiling of cetuximab by a combination of intact, middle-up, middle-down and bottom-up ESI and MALDI mass spectrometry techniques Ayoub, Daniel; Jabs, Wolfgang; Resemann, Anja mAbs, Vol. 5, Issue 5 https://doi.org/10.4161/mabs.25423	journal	September 2013

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