Immunogenicity of Biotherapeutics: Causes and Association with Posttranslational Modifications

Secukinumab, a novel anti–IL-17A antibody, shows low immunogenicity potential in human in vitro assays comparable to other marketed biotherapeutics with low clinical immunogenicity

(2016) Anette Karle et al.   mAbs

Posttranslational Modifications and the Immunogenicity of Biotherapeutics

(2016) Roy Jefferis   Journal of Immunology Research

Immunogenicity, drug trough levels and therapeutic response in patients with rheumatoid arthritis or ankylosing spondylitis after 24-week golimumab treatment

(2015) Der-Yuan Chen et al.   ANNALS OF THE RHEUMATIC DISEASES

Fc glycans of therapeutic antibodies as critical quality attributes

(2015) Dietmar Reusch et al.   GLYCOBIOLOGY

Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial

(2015) Naiyer A Rizvi et al.   LANCET ONCOLOGY

Cross-reactive and pre-existing antibodies to therapeutic antibodies—Effects on treatment and immunogenicity

(2015) Karin A van Schie et al.   mAbs

Pembrolizumab

(2015) Leila Khoja et al.   Journal for ImmunoTherapy of Cancer

The Association between Clinical Response to Ustekinumab and Immunogenicity to Ustekinumab and Prior Adalimumab

(2015) Hsien-Yi Chiu et al.   PLoS One

Adalimumab dose escalation is effective for managing secondary loss of response in Crohn's disease

(2014) C. Ma et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Bioanalytical strategy used in development of pharmacokinetic (PK) methods that support biosimilar programs

(2014) Alex Colbert et al.   mAbs

Autoantibodies to Posttranslational Modifications in Rheumatoid Arthritis

(2014) Agata N. Burska et al.   MEDIATORS OF INFLAMMATION

A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions

(2014) Sabine Maier et al.   Cancer Medicine

T-cell dependent immunogenicity of protein therapeutics: Preclinical assessment and mitigation

(2013) Vibha Jawa et al.   CLINICAL IMMUNOLOGY

Immunogenicity of therapeutic proteins: Influence of aggregation

(2013) Kirsty D. Ratanji et al.   Journal of Immunotoxicology

Monitoring of adalimumab and antibodies-to-adalimumab levels in patient serum by the homogeneous mobility shift assay

(2013) Shui-Long Wang et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Identification of Oxidation Sites and Covalent Cross-Links in Metal Catalyzed Oxidized Interferon Beta-1a: Potential Implications for Protein Aggregation and Immunogenicity

(2013) Riccardo Torosantucci et al.   MOLECULAR PHARMACEUTICS

Endogenous factor VIII synthesis from the intron 22–inverted F8 locus may modulate the immunogenicity of replacement therapy for hemophilia A

(2013) Gouri Shankar Pandey et al.   NATURE MEDICINE

Rituximab for the treatment of rheumatoid arthritis: an update

(2013) Chi Chiu Mok   Drug Design Development and Therapy

Analysis of Nonhuman N-Glycans as the Minor Constituents in Recombinant Monoclonal Antibody Pharmaceuticals

(2012) Eiki Maeda et al.   ANALYTICAL CHEMISTRY

Minimizing immunogenicity of biopharmaceuticals by controlling critical quality attributes of proteins

(2012) Miranda M. C. van Beers et al.   Biotechnology Journal

Measurement of Anti-Erythropoiesis-Stimulating Agent IgG4 Antibody as an Indicator of Antibody-Mediated Pure Red Cell Aplasia

(2012) Dohan K. Weeraratne et al.   Clinical and Vaccine Immunology

Successful immune tolerance induction to enzyme replacement therapy in CRIM-negative infantile Pompe disease

(2012) Yoav H. Messinger et al.   GENETICS IN MEDICINE

Highly Aggregated Antibody Therapeutics Can Enhance thein VitroInnate and Late-stage T-cell Immune Responses

(2012) Marisa K. Joubert et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

Development and characterization of a human antibody reference panel against erythropoietin suitable for the standardization of ESA immunogenicity testing

(2012) Daniel T. Mytych et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: new insights

(2012) Iain C. Macdougall et al.   KIDNEY INTERNATIONAL

Aggregation, immune complexes and immunogenicity

(2012) Roy Jefferis   mAbs

Interchangeability, immunogenicity and biosimilars

(2012) Hans C Ebbers et al.   NATURE BIOTECHNOLOGY

Alemtuzumab Therapy for Multiple Sclerosis

(2012) Alasdair J. Coles   Neurotherapeutics

Chemical Modifications in Aggregates of Recombinant Human Insulin Induced by Metal-Catalyzed Oxidation: Covalent Cross-Linking via Michael Addition to Tyrosine Oxidation Products

(2012) Riccardo Torosantucci et al.   PHARMACEUTICAL RESEARCH

Development and validation of cell-based assays for the detection of neutralizing antibodies to drug products: a practical approach

(2012) Pierre Jolicoeur et al.   Bioanalysis

Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naive, rheumatoid arthritis patients with an inadequate response to methotrexate: a randomised, double-blind, placebo-controlled clinical trial

(2011) P. C. Taylor et al.   ANNALS OF THE RHEUMATIC DISEASES

Insulin allergy

(2011) Mohammad K. Ghazavi et al.   CLINICS IN DERMATOLOGY

High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans

(2011) A. M. Goetze et al.   GLYCOBIOLOGY

Alpha 1,3-Galactosyltransferase Deficiency in Pigs Increases Sialyltransferase Activities That Potentially Raise Non-Gal Xenoantigenicity

(2011) Jong-Yi Park et al.   JOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY

The genomic sequence of the Chinese hamster ovary (CHO)-K1 cell line

(2011) Xun Xu et al.   NATURE BIOTECHNOLOGY

Immunogenicity of Therapeutic Proteins: The Use of Animal Models

(2011) Vera Brinks et al.   PHARMACEUTICAL RESEARCH

Tungsten-Induced Denaturation and Aggregation of Epoetin Alfa During Primary Packaging as a Cause of Immunogenicity

(2011) Andreas Seidl et al.   PHARMACEUTICAL RESEARCH

Oxidized and Aggregated Recombinant Human Interferon Beta is Immunogenic in Human Interferon Beta Transgenic Mice

(2011) Miranda M. C. van Beers et al.   PHARMACEUTICAL RESEARCH

Potential impact of the non-human sialic acid N-glycolylneuraminic acid on transplant rejection risk

(2011) Vered Padler-Karavani et al.   XENOTRANSPLANTATION

Overcoming immunogenicity associated with the use of biopharmaceuticals

(2011) Michael G Tovey et al.   Expert Review of Clinical Pharmacology

Glycosylation of Therapeutic Proteins

(2010) Ricardo J. Solá et al.   BIODRUGS

Structural changes induced by the deamidation and isomerization of asparagine revealed by the crystal structure of Ustilago sphaerogena ribonuclease U2B

(2010) Shuji Noguchi   BIOPOLYMERS

Generic substitution: a need for clarification

(2010) Gregory M. Peterson   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Inhibitors of propagation of coagulation (factors VIII, IX and XI): a review of current therapeutic practice

(2010) Massimo Franchini et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Post-translational modifications of protein biopharmaceuticals

(2010) Gary Walsh   DRUG DISCOVERY TODAY

Impact of Product-Related Factors on Immunogenicity of Biotherapeutics

(2010) Satish Kumar Singh   JOURNAL OF PHARMACEUTICAL SCIENCES

Potential aggregation prone regions in biotherapeutics

(2010) Xiaoling Wang et al.   mAbs

Human immunoglobulin allotypes

(2010) Roy Jefferis et al.   mAbs

Assessing monoclonal antibody product quality attribute criticality through clinical studies

(2010) Andrew M. Goetze et al.   mAbs

Canakinumab

(2010) Eugen Dhimolea   mAbs

The immunogenicity of humanized and fully human antibodies

(2010) Fiona A. Harding et al.   mAbs

Biopharmaceutical benchmarks 2010

(2010) Gary Walsh   NATURE BIOTECHNOLOGY

Implications of the presence of N-glycolylneuraminic acid in recombinant therapeutic glycoproteins

(2010) Darius Ghaderi et al.   NATURE BIOTECHNOLOGY

Aggregated Recombinant Human Interferon Beta Induces Antibodies but No Memory in Immune-Tolerant Transgenic Mice

(2010) Miranda M. C. van Beers et al.   PHARMACEUTICAL RESEARCH

Stability of Protein Pharmaceuticals: An Update

(2010) Mark Cornell Manning et al.   PHARMACEUTICAL RESEARCH

Golimumab Therapy of Rheumatoid Arthritis: An Overview

(2010) I. Zidi et al.   SCANDINAVIAN JOURNAL OF IMMUNOLOGY

Reducing risk, improving outcomes: Bioengineering less immunogenic protein therapeutics

(2009) Anne S. De Groot et al.   CLINICAL IMMUNOLOGY

Effect of Route of Administration of Human Recombinant Factor VIII on Its Immunogenicity in Hemophilia A Mice

(2009) Aaron Peng et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Precipitation of a Monoclonal Antibody by Soluble Tungsten

(2009) JARED S. BEE et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

How to systematically evaluate immunogenicity of therapeutic proteins – regulatory considerations

(2009) Eva-Maria Jahn et al.   New Biotechnology

Immunological mechanism underlying the immune response to recombinant human protein therapeutics

(2009) Melody Sauerborn et al.   TRENDS IN PHARMACOLOGICAL SCIENCES

Immunogenicity negatively influences the outcome of adalimumab treatment in Crohn’s disease

(2008) R. L. WEST et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis

(2008) T R D J Radstake et al.   ANNALS OF THE RHEUMATIC DISEASES

Neutralizing antibodies to therapeutic enzymes: considerations for testing, prevention and treatment

(2008) Jinhai Wang et al.   NATURE BIOTECHNOLOGY

Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose

(2008) Christine H. Chung et al.   NEW ENGLAND JOURNAL OF MEDICINE

Consequence of neo-antigenicity of the 'altered self'

(2008) P. Eggleton et al.   RHEUMATOLOGY

Factors that contribute to the immmunogenicity of therapeutic recombinant human proteins

(2008) Ilya Mukovozov et al.   THROMBOSIS AND HAEMOSTASIS

Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus

(2008) Richard Furie et al.   ARTHRITIS RESEARCH & THERAPY

Past, Present, and Future Technologies for Oral Delivery of Therapeutic Proteins

(2007) Rajesh Singh et al.   JOURNAL OF PHARMACEUTICAL SCIENCES