Simultaneous Monitoring of Monoclonal Antibody Variants by Strong Cation-Exchange Chromatography Hyphenated to Mass Spectrometry to Assess Quality Attributes of Rituximab-Based Biotherapeutics

C-terminal lysine clipping of IgG1: impact on binding to human FcγRIIIa and neonatal Fc receptors

(2021) Valegh Faid et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Proteomic Profiling of IgG1 Producing CHO Cells Using LC/LC-SPS-MS3: The Effects of Bioprocessing Conditions on Productivity and Product Quality

(2021) Lisa Strasser et al.   Frontiers in Bioengineering and Biotechnology

Comparative Elucidation of Cetuximab Heterogeneity on the Intact Protein Level by Cation Exchange Chromatography and Capillary Electrophoresis Coupled to Mass Spectrometry

(2020) Florian Fussl et al.   ANALYTICAL CHEMISTRY

The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019

(2020) Hye-Na Kang et al.   BIOLOGICALS

Anion exchange chromatography – Mass spectrometry for monitoring multiple quality attributes of erythropoietin biopharmaceuticals

(2020) Guusje van Schaick et al.   ANALYTICA CHIMICA ACTA

Optimisation of the use of sliding window deconvolution for comprehensive characterisation of trastuzumab and adalimumab charge variants by native high resolution mass spectrometry

(2020) Silvia Millán-Martín et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Dilute-and-shoot analysis of therapeutic monoclonal antibody variants in fermentation broth: a method capability study

(2019) Christof Regl et al.   mAbs

Proteomics insight into the production of monoclonal antibody

(2019) Ningning Xu et al.   BIOCHEMICAL ENGINEERING JOURNAL

Comparison of the Efficacy of Innovator Rituximab and its Biosimilars in Diffuse Large B Cell Lymphoma Patients: A Retrospective Analysis

(2019) Aniket Bankar et al.   INDIAN JOURNAL OF HEMATOLOGY AND BLOOD TRANSFUSION

Multifaceted assessment of rituximab biosimilarity: The impact of glycan microheterogeneity on Fc function

(2019) Jukyung Kang et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Charge Variant Analysis of Monoclonal Antibodies Using Direct Coupled pH Gradient Cation Exchange Chromatography to High-Resolution Native Mass Spectrometry

(2018) Florian Füssl et al.   ANALYTICAL CHEMISTRY

The “less-is-more” in therapeutic antibodies: Afucosylated anti-cancer antibodies with enhanced antibody-dependent cellular cytotoxicity

(2018) Natasha A. Pereira et al.   mAbs

The importance of handling high-value biologicals: Physico-chemical instability and immunogenicity of monoclonal antibodies (Review)

(2018) Tomislav Laptoš et al.   Experimental and Therapeutic Medicine

Native mass spectrometry combined with enzymatic dissection unravels glycoform heterogeneity of biopharmaceuticals

(2018) Therese Wohlschlager et al.   Nature Communications

Past, Present, and Future of Rituximab—The World’s First Oncology Monoclonal Antibody Therapy

(2018) Timothy M. Pierpont et al.   Frontiers in Oncology

Rapid charge variant analysis of monoclonal antibodies to support lead candidate biopharmaceutical development

(2018) Anne Trappe et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Comprehensive characterisation of the heterogeneity of adalimumab via charge variant analysis hyphenated on-line to native high resolution Orbitrap mass spectrometry

(2018) Florian Füssl et al.   mAbs

Determination of isoelectric points and relative charge variants of 23 therapeutic monoclonal antibodies

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

Assessment of structural and functional similarity of biosimilar products: Rituximab as a case study

(2017) Neh Nupur et al.   mAbs

Forced degradation of recombinant monoclonal antibodies: A practical guide

(2017) Christine Nowak et al.   mAbs

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

SpeB proteolysis with imaged capillary isoelectric focusing for the characterization of domain-specific charge heterogeneities of reference and biosimilar Rituximab

(2016) Zichuan Zhang et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Characterization of the N-Terminal Heterogeneities of Monoclonal Antibodies Using In-Gel Charge Derivatization of α-Amines and LC-MS/MS

(2015) Daniel Ayoub et al.   ANALYTICAL CHEMISTRY

Cutting-edge mass spectrometry characterization of originator, biosimilar and biobetter antibodies

(2015) Alain Beck et al.   JOURNAL OF MASS SPECTROMETRY

Method development for the separation of monoclonal antibody charge variants in cation exchange chromatography, Part I: Salt gradient approach

(2015) Szabolcs Fekete et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Ion-exchange chromatography for the characterization of biopharmaceuticals

(2015) Szabolcs Fekete et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Method development for the separation of monoclonal antibody charge variants in cation exchange chromatography, Part II: pH gradient approach

(2015) Szabolcs Fekete et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Human IgG is produced in a pro-form that requires clipping of C-terminal lysines for maximal complement activation

(2015) Ewald TJ van den Bremer et al.   mAbs

The therapeutic monoclonal antibody market

(2014) Dawn M Ecker et al.   mAbs

In vitro and in vivo modifications of recombinant and human IgG antibodies

(2014) Hongcheng Liu et al.   mAbs

Structural comparison of two anti-CD20 monoclonal antibody drug products using middle-down mass spectrometry

(2013) Bo Wang et al.   ANALYST

Investigation of the correlation between charge and glycosylation of IgG1 variants by liquid chromatography–mass spectrometry

(2013) Jia-Ming Yang et al.   ANALYTICAL BIOCHEMISTRY

Analysis of recombinant monoclonal antibodies by capillary zone electrophoresis

(2013) Carlos E. Espinosa- de la Garza et al.   ELECTROPHORESIS

Charge heterogeneity profiling of monoclonal antibodies using low ionic strength ion-exchange chromatography and well-controlled pH gradients on monolithic columns

(2013) Mohammad Talebi et al.   JOURNAL OF CHROMATOGRAPHY A

PHYSICOCHEMICAL PROPERTIES OF RITUXIMAB

(2013) Luis F. Flores-Ortiz et al.   JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES

Proteoform: a single term describing protein complexity

(2013) Lloyd M Smith et al.   NATURE METHODS

Analytical characterization of biosimilar antibodies and Fc-fusion proteins

(2013) Alain Beck et al.   TRAC-TRENDS IN ANALYTICAL CHEMISTRY

Characterization of Therapeutic Antibodies and Related Products

(2012) Alain Beck et al.   ANALYTICAL CHEMISTRY

Biosimilar, Biobetter, and Next Generation Antibody Characterization by Mass Spectrometry

(2012) Alain Beck et al.   ANALYTICAL CHEMISTRY

Characterization of the basic charge variants of a human IgG1

(2012) Timothy Kaschak et al.   mAbs

Chromatographic analysis of the acidic and basic species of recombinant monoclonal antibodies

(2012) Yi Du et al.   mAbs

Production, characterization and pharmacokinetic properties of antibodies with N-linked Mannose-5 glycans

(2012) Marcella Yu et al.   mAbs

Biosimilars—why terminology matters

(2011) Martina Weise et al.   NATURE BIOTECHNOLOGY

A study in glycation of a therapeutic recombinant humanized monoclonal antibody: Where it is, how it got there, and how it affects charge-based behavior

(2007) Cynthia Quan et al.   ANALYTICAL BIOCHEMISTRY