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dc.contributor.author
Brinson, Robert G.
dc.contributor.author
Marino, John P.
dc.contributor.author
Delaglio, Frank
dc.contributor.author
Arbogast, Luke W.
dc.contributor.author
Evans, Ryan M.
dc.contributor.author
Kearsley, Anthony
dc.contributor.author
Gingras, Geneviève
dc.contributor.author
Ghasriani, Houman
dc.contributor.author
Aubin, Yves
dc.contributor.author
Pierens, Gregory K.
dc.contributor.author
Jia, Xinying
dc.contributor.author
Mobli, Mehdi
dc.contributor.author
Grant, Hamish G.
dc.contributor.author
Keizer, David W.
dc.contributor.author
Schweimer, Kristian
dc.contributor.author
Ståhle, Jonas
dc.contributor.author
Widmalm, Göran
dc.contributor.author
Zartler, Edward R.
dc.contributor.author
Lawrence, Chad W.
dc.contributor.author
Reardon, Patrick N.
dc.contributor.author
Cort, John R.
dc.contributor.author
Xu, Ping
dc.contributor.author
Ni, Feng
dc.contributor.author
Yanaka, Saeko
dc.contributor.author
Kato, Koichi
dc.contributor.author
Parnham, Stuart R.
dc.contributor.author
Tsao, Desiree
dc.contributor.author
Blomgren, Andreas
dc.contributor.author
Rundlöf, Torgny
dc.contributor.author
Trieloff, Nils
dc.contributor.author
Schmieder, Peter
dc.contributor.author
Ross, Alfred
dc.contributor.author
Skidmore, Ken
dc.contributor.author
Chen, Kang
dc.contributor.author
Freedberg, Darón I.
dc.contributor.author
Suter-Stahel, Thea
dc.contributor.author
Wider, Gerhard
dc.contributor.author
Ilc, Gregor
dc.contributor.author
Plavec, Janez
dc.contributor.author
Bradley, Scott A.
dc.contributor.author
Baldisseri, Donna M.
dc.contributor.author
Sforça, Maurício L.
dc.contributor.author
Zeri, Ana C.
dc.contributor.author
Wei, Julie Yu
dc.contributor.author
Szabo, Christina M.
dc.contributor.author
Amezcua, Carlos A.
dc.contributor.author
Jordan, John B.
dc.contributor.author
Wikström, Mats
dc.date.accessioned
2019-02-08T13:51:26Z
dc.date.available
2019-02-01T04:45:42Z
dc.date.available
2019-02-08T13:51:26Z
dc.date.issued
2019
dc.identifier.other
10.1080/19420862.2018.1544454
en_US
dc.identifier.uri
http://hdl.handle.net/20.500.11850/322314
dc.identifier.doi
10.3929/ethz-b-000322314
dc.description.abstract
The increased interest in using monoclonal antibodies (mAbs) as a platform for biopharmaceuticals has led to the need for new analytical techniques that can precisely assess physicochemical properties of these large and very complex drugs for the purpose of correctly identifying quality attributes (QA). One QA, higher order structure (HOS), is unique to biopharmaceuticals and essential for establishing consistency in biopharmaceutical manufacturing, detecting process-related variations from manufacturing changes and establishing comparability between biologic products. To address this measurement challenge, two-dimensional nuclear magnetic resonance spectroscopy (2D-NMR) methods were introduced that allow for the precise atomic-level comparison of the HOS between two proteins, including mAbs. Here, an inter-laboratory comparison involving 26 industrial, government and academic laboratories worldwide was performed as a benchmark using the NISTmAb, from the National Institute of Standards and Technology (NIST), to facilitate the translation of the 2D-NMR method into routine use for biopharmaceutical product development. Two-dimensional 1H,15N and 1H,13C NMR spectra were acquired with harmonized experimental protocols on the unlabeled Fab domain and a uniformly enriched-15N, 20%-13C-enriched system suitability sample derived from the NISTmAb. Chemometric analyses from over 400 spectral maps acquired on 39 different NMR spectrometers ranging from 500 MHz to 900 MHz demonstrate spectral fingerprints that are fit-for-purpose for the assessment of HOS. The 2D-NMR method is shown to provide the measurement reliability needed to move the technique from an emerging technology to a harmonized, routine measurement that can be generally applied with great confidence to high precision assessments of the HOS of mAb-based biotherapeutics.
en_US
dc.format
application/pdf
en_US
dc.language.iso
en
en_US
dc.publisher
Taylor & Francis
en_US
dc.rights.uri
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subject
monoclonal antibody (mAb) therapeutics
en_US
dc.subject
NISTmAb
en_US
dc.subject
higher order structure
en_US
dc.subject
nuclear magnetic resonance spectroscopy (NMR)
en_US
dc.subject
comparability
en_US
dc.subject
chemometrics
en_US
dc.title
Enabling adoption of 2D-NMR for the higher order structure assessment of monoclonal antibody therapeutics
en_US
dc.type
Journal Article
dc.rights.license
Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
dc.date.published
2018-12
ethz.journal.title
mAbs
ethz.journal.volume
11
en_US
ethz.journal.issue
1
en_US
ethz.pages.start
94
en_US
ethz.pages.end
105
en_US
ethz.version.deposit
publishedVersion
en_US
ethz.identifier.wos
ethz.identifier.scopus
ethz.publication.place
Philadelphia, PA
en_US
ethz.publication.status
published
en_US
ethz.date.deposited
2019-02-01T04:45:44Z
ethz.source
SCOPUS
ethz.eth
yes
en_US
ethz.availability
Open access
en_US
ethz.rosetta.installDate
2019-02-08T13:51:48Z
ethz.rosetta.lastUpdated
2020-02-15T17:19:00Z
ethz.rosetta.versionExported
true
ethz.COinS
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