Quantitative N-Glycan Profiling of Therapeutic Monoclonal Antibodies Performed by Middle-Up Level HILIC-HRMS Analysis

FDA approves 100th monoclonal antibody product

(2021) Asher Mullard   NATURE REVIEWS DRUG DISCOVERY

Development of a 3D-LC/MS Workflow for Fast, Automated, and Effective Characterization of Glycosylation Patterns of Biotherapeutic Products

(2020) Julien Camperi et al.   ANALYTICAL CHEMISTRY

Therapeutic Fc‐fusion proteins: Current analytical strategies

(2020) Bastiaan L. Duivelshof et al.   JOURNAL OF SEPARATION SCIENCE

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

(2019) Bastiaan L. Duivelshof et al.   ANALYTICA CHIMICA ACTA

Implementation of a High-Resolution Liquid Chromatography–Mass Spectrometry Method in Quality Control Laboratories for Release and Stability Testing of a Commercial Antibody Product

(2019) Izabela Sokolowska et al.   ANALYTICAL CHEMISTRY

Therapeutic monoclonal antibody N-glycosylation – Structure, function and therapeutic potential

(2018) Florian Cymer et al.   BIOLOGICALS

Multi-site N-Glycan mapping study 2: UHPLC

(2018) Ákos Szekrényes et al.   ELECTROPHORESIS

Characterization of an antibody-drug conjugate by hydrophilic interaction chromatography coupled to mass spectrometry

(2018) Valentina D’Atri et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Monoclonal antibody N-glycosylation profiling using capillary electrophoresis – Mass spectrometry: Assessment and method validation

(2018) Jérémie Giorgetti et al.   TALANTA

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

(2018) Valentina D'Atri et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Comparison of 2-Aminobenzamide, Procainamide and RapiFluor-MS as Derivatizing Agents for High-Throughput HILIC-UPLC-FLR-MS N-glycan Analysis

(2018) Toma Keser et al.   Frontiers in Chemistry

Orthogonal Middle-up Approaches for Characterization of the Glycan Heterogeneity of Etanercept by Hydrophilic Interaction Chromatography Coupled to High-Resolution Mass Spectrometry

(2018) Valentina D’Atri et al.   ANALYTICAL CHEMISTRY

Protocols for the analytical characterization of therapeutic monoclonal antibodies. II – Enzymatic and chemical sample preparation

(2017) Balazs Bobaly et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Analysis of recombinant monoclonal antibodies in hydrophilic interaction chromatography: A generic method development approach

(2017) Balázs Bobály et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Glycosylation profile and biological activity of Remicade® compared with Flixabi® and Remsima®

(2017) Changsoo Lee et al.   mAbs

High-Throughput, Automated Protein A Purification Platform with Multiattribute LC–MS Analysis for Advanced Cell Culture Process Monitoring

(2016) Jia Dong et al.   ANALYTICAL CHEMISTRY

State-of-the-art technologies for rapid and high-throughput sample preparation and analysis ofN-glycans from antibodies

(2016) Udayanath Aich et al.   ELECTROPHORESIS

N-glycosylation heterogeneity and the influence on structure, function and pharmacokinetics of monoclonal antibodies and Fc fusion proteins

(2016) Fabian Higel et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Advanced assessment of the physicochemical characteristics of Remicade® and Inflectra® by sensitive LC/MS techniques

(2016) Jing Fang et al.   mAbs

Rapid Preparation of Released N-Glycans for HILIC Analysis Using a Labeling Reagent that Facilitates Sensitive Fluorescence and ESI-MS Detection

(2015) Matthew A. Lauber et al.   ANALYTICAL CHEMISTRY

Fc glycans of therapeutic antibodies as critical quality attributes

(2015) Dietmar Reusch et al.   GLYCOBIOLOGY

Consistency of quality attributes for the glycosylated monoclonal antibody Humira® (adalimumab)

(2015) Paul W Tebbey et al.   mAbs

Comparison of methods for the analysis of therapeutic immunoglobulin G Fc-glycosylation profiles—Part 1: Separation-based methods

(2014) Dietmar Reusch et al.   mAbs

Characterization of Therapeutic Antibodies and Related Products

(2012) Alain Beck et al.   ANALYTICAL CHEMISTRY

Marketing approval of mogamulizumab

(2012) Alain Beck et al.   mAbs

Advances in the assessment and control of the effector functions of therapeutic antibodies

(2011) Xu-Rong Jiang et al.   NATURE REVIEWS DRUG DISCOVERY