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  • 1. Brinson, Robert G.
    et al.
    Marino, John P.
    Delaglio, Frank
    Arbogast, Luke W.
    Evans, Ryan M.
    Kearsley, Anthony
    Gingras, Genevieve
    Ghasriani, Houman
    Aubin, Yves
    Pierens, Gregory K.
    Jia, Xinying
    Mobli, Mehdi
    Grant, Hamish G.
    Keizer, David W.
    Schweimer, Kristian
    Ståhle, Jonas
    Stockholm University, Faculty of Science, Department of Organic Chemistry.
    Widmalm, Göran
    Stockholm University, Faculty of Science, Department of Organic Chemistry.
    Zartler, Edward R.
    Lawrence, Chad W.
    Reardon, Patrick N.
    Cort, John R.
    Xu, Ping
    Ni, Feng
    Yanaka, Saeko
    Kato, Koichi
    Parnham, Stuart R.
    Tsao, Desiree
    Blomgren, Andreas
    Rundlof, Torgny
    Trieloff, Nils
    Schmieder, Peter
    Ross, Alfred
    Skidmore, Ken
    Chen, Kang
    Keire, David
    Freedberg, Daron I.
    Suter-Stahel, Thea
    Wider, Gerhard
    Ilc, Gregor
    Plavec, Janez
    Bradley, Scott A.
    Baldisseri, Donna M.
    Sforca, Mauricio Luis
    de Mattos Zeri, Ana Carolina
    Wei, Julie Yu
    Szabo, Christina M.
    Amezcua, Carlos A.
    Jordan, John B.
    Wikström, Mats
    Enabling adoption of 2D-NMR for the higher order structure assessment of monoclonal antibody therapeutics2019In: mAbs, ISSN 1942-0862, E-ISSN 1942-0870, Vol. 11, no 1, p. 94-105Article in journal (Refereed)
    Abstract [en]

    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 H-1,N-15 and H-1,C-13 NMR spectra were acquired with harmonized experimental protocols on the unlabeled Fab domain and a uniformly enriched-N-15, 20%-C-13-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.

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