Protocols for the analytical characterization of therapeutic monoclonal antibodies. III – Denaturing chromatographic techniques hyphenated to mass spectrometry

D’Atri, Valentina; Goyon, Alexandre; Bobály, Balázs; Beck, Alain; Fekete, Szabolcs; Guillarme, Davy

doi:10.1016/j.jchromb.2018.08.013

Cited by 27 publications

(26 citation statements)

References 23 publications

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“…Another interesting approach is the middle‐up analysis of peptibodies. Chemical reduction of the disulfide bonds between the single Fc‐chains creates subunits of around 30 kDa that can be easily analyzed using RPLC‐ and HILIC‐MS for the most common PTMs [67]. Further size reduction of the subunits by enzymatic digestion, using IdeS , has little added value for romiplostim, since the biological active peptide is coupled to the C‐terminal end of the Fc‐domain.…”

Section: Case Studies Related To the Analytical Characterization Of Fmentioning

confidence: 99%

“…For more information on the cleavage specificity of different enzymes, Bobaly et al described protocols to perform tryptic proteolysis, IdeS and papain digestion, reduction as well as deglycosylation by PNGase F and EndoS2 enzymes and overviewed general sample preparation approaches used to attain peptide, subunit, and glycan level analysis [66,67].…”

Section: Confirmation Of Primary Structure By Ms Analysismentioning

confidence: 99%

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Therapeutic Fc‐fusion proteins: Current analytical strategies

Duivelshof

Murisier

Camperi

et al. 2020

J of Separation Science

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Fc-Fusion proteins represent a successful class of biopharmaceutical products, with already 13 drugs approved in the European Union and United States as well as three biosimilar versions of etanercept. Fc-Fusion products combine tailored pharmacological properties of biological ligands, together with multiple functions of the fragment crystallizable domain of immunoglobulins. There is a great diversity in terms of possible biological ligands, including the extracellular domains of natural receptors, functionally active peptides, recombinant enzymes, and genetically engineered binding constructs acting as cytokine traps. Due to their highly diverse structures, the analytical characterization of Fc-Fusion proteins is far more complex than that of monoclonal antibodies and requires the use and development of additional product-specific methods over conventional generic/platform methods. This can be explained, for example, by the presence of numerous sialic acids, leading to high diversity in terms of iso-

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Section: Case Studies Related To the Analytical Characterization Of Fmentioning

confidence: 99%

Section: Confirmation Of Primary Structure By Ms Analysismentioning

confidence: 99%

Therapeutic Fc‐fusion proteins: Current analytical strategies

Duivelshof

Murisier

Camperi

et al. 2020

J of Separation Science

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“…Both the top and middle-up strategies provide an attractive approach for fast and robust analysis of batch-to-batch variability in major glycoform species, with the benefit of simple sample preparation and analysis [63]. This is of specific interest during biosimilar development, to rapidly screen for differences in major glycan species between the originator product and proposed product.…”

Section: Top and Middle-up Levelmentioning

confidence: 99%

“…After 20 years of HILIC being the core module in analyzing fluorescently labeled released glycans, the introduction of new sub-2 mm and widepore (300 Å) stationary phases has opened new possibilities for separations of released glycans, glycopeptides and intact glycoproteins [109]. Separation in HILIC is based on hydrophilic interactions (mostly through hydrogen bonds) and therefore provides orthogonal information to reversed phase liquid chromatography (RPLC) in terms of elution order and selectivity [63]. Periat et al were first to show the potential of HILIC for the characterization of biopharmaceuticals, by demonstrating the separation of major mAb glycoforms at the middle-up level, which was not obtained with RPLC and ion exchange (IEX) separation modes [110].…”

Section: Middle-up Analysis Of Glycoforms Using Hydrophilic Interactimentioning

confidence: 99%

Glycosylation of biosimilars: Recent advances in analytical characterization and clinical implications

Duivelshof

Jiskoot

Beck

et al. 2019

Analytica Chimica Acta

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License: Article 25fa pilot End User Agreement This publication is distributed under the terms of Article 25fa of the Dutch Copyright Act (Auteurswet) with explicit consent by the author. Dutch law entitles the maker of a short scientific work funded either wholly or partially by Dutch public funds to make that work publicly available for no consideration following a reasonable period of time after the work was first published, provided that clear reference is made to the source of the first publication of the work. This publication is distributed under The Association of Universities in the Netherlands (VSNU) 'Article 25fa implementation' pilot project. In this pilot research outputs of researchers employed by Dutch Universities that comply with the legal requirements of Article 25fa of the Dutch Copyright Act are distributed online and free of cost or other barriers in institutional repositories. Research outputs are distributed six months after their first online publication in the original published version and with proper attribution to the source of the original publication. You are permitted to download and use the publication for personal purposes. All rights remain with the author(s) and/or copyrights owner(s) of this work. Any use of the publication other than authorised under this licence or copyright law is prohibited. If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons.

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“…Hence, a large array of separation techniques in liquid phase like high performance liquid chromatography (HPLC) or capillary electrophoresis (CE) were developed for quality control of biopharmaceutics [12][13][14][15]. These complementary methods allow the separation of the main mAbs isoforms from the modified variants in order to provide a detailed characterization over the different level defining the structure of the protein.…”

Section: Introductionmentioning

confidence: 99%

Insights from capillary electrophoresis approaches for characterization of monoclonal antibodies and antibody drug conjugates in the period 2016–2018

Lechner

Giorgetti

Gahoual

et al. 2019

Journal of Chromatography B

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Monoclonal antibodies (mAbs) and their related products as antibody-drug-conjugates (ADCs) or biosimilars represent a constantly growing class of molecules therapeutic proteins used as treatment against numerous diseases. These compounds can undergo several modifications which could alter the efficiency of treatments. In this context, several analytical methods were designed to deliver a comprehensive structural characterization and guarantee the quality of biotherapeutics. Capillary electrophoresis (CE) is considered today as a major technique for the analysis of biotherapeutics due to benefic characteristics as high resolution separation and miniaturized format. Different CE modes have been developed to characterize mAbs at different levels such as capillary gel electrophoresis (CGE), capillary isoelectric focusing (cIEF), and capillary zone electrophoresis (CZE). Recent developments in CE-mass spectrometry (MS) coupling assessed this technology as a promising tool to obtain high level structural characterization of biopharmaceuticals. Moreover, upcoming techniques such as 2D CE-MS and microfluidic systems are now emerging to offer new possibilities beyond actual limits. This review will be dedicated to discuss the state-of-the-art CE-based methods for the characterization of mAbs and ADCs in the period 2016-2018.

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Protocols for the analytical characterization of therapeutic monoclonal antibodies. III – Denaturing chromatographic techniques hyphenated to mass spectrometry

Cited by 27 publications

References 23 publications

Therapeutic Fc‐fusion proteins: Current analytical strategies

Therapeutic Fc‐fusion proteins: Current analytical strategies

Glycosylation of biosimilars: Recent advances in analytical characterization and clinical implications

Insights from capillary electrophoresis approaches for characterization of monoclonal antibodies and antibody drug conjugates in the period 2016–2018

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