Immunogenicity assessment during the development of protein therapeutics

Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab

(2017) Paul M Ridker et al.   NEW ENGLAND JOURNAL OF MEDICINE

Quantitative analysis of the CD4+ T cell response to therapeutic antibodies in healthy donors using a novel T cell:PBMC assay

(2017) Heidi S. Schultz et al.   PLoS One

Immunology by numbers: quantitation of antigen presentation completes the quantitative milieu of systems immunology!

(2016) Anthony W Purcell et al.   CURRENT OPINION IN IMMUNOLOGY

Peginesatide for the treatment of anemia due to chronic kidney disease – an unfulfilled promise

(2016) Terhi Hermanson et al.   Expert Opinion On Drug Safety

TRUST trial: BAY 86-6150 use in haemophilia with inhibitors and assessment for immunogenicity

(2016) J. Mahlangu et al.   HAEMOPHILIA

Subvisible Particle Content, Formulation, and Dose of an Erythropoietin Peptide Mimetic Product Are Associated With Severe Adverse Postmarketing Events

(2016) Joseph Kotarek et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility

(2015) Meenu Wadhwa et al.   BIOLOGICALS

Poor correlation between T-cell activation assays and HLA-DR binding prediction algorithms in an immunogenic fragment of Pseudomonas exotoxin A

(2015) Ronit Mazor et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Changes in the amino acid sequence of the recombinant human factor VIIa analog, vatreptacog alfa, are associated with clinical immunogenicity

(2015) J. N. Mahlangu et al.   JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Fc fusion as a platform technology: potential for modulating immunogenicity

(2015) Ditza Levin et al.   TRENDS IN BIOTECHNOLOGY

Immunodominance of CD4 T Cells to Foreign Antigens Is Peptide Intrinsic and Independent of Molecular Context: Implications for Vaccine Design

(2014) J. M. Weaver et al.   JOURNAL OF IMMUNOLOGY

Biopharmaceutical benchmarks 2014

(2014) Gary Walsh   NATURE BIOTECHNOLOGY

A Mathematical Model of the Effect of Immunogenicity on Therapeutic Protein Pharmacokinetics

(2013) Xiaoying Chen et al.   AAPS Journal

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

(2013) Vibha Jawa et al.   CLINICAL IMMUNOLOGY

Three deaths sink Affymax

(2013) Laura DeFrancesco   NATURE BIOTECHNOLOGY

Building better drugs: developing and regulating engineered therapeutic proteins

(2013) Chava Kimchi-Sarfaty et al.   TRENDS IN PHARMACOLOGICAL SCIENCES

Polymorphisms in the F8 Gene and MHC-II Variants as Risk Factors for the Development of Inhibitory Anti-Factor VIII Antibodies during the Treatment of Hemophilia A: A Computational Assessment

(2013) Gouri Shankar Pandey et al.   PLoS Computational Biology

The Utility of Modeling and Simulation Approaches to Evaluate Immunogenicity Effect on the Therapeutic Protein Pharmacokinetics

(2012) Juan Jose Perez Ruixo et al.   AAPS Journal

F8 gene mutation type and inhibitor development in patients with severe hemophilia A: systematic review and meta-analysis

(2012) S. C. Gouw et al.   BLOOD

Managing uncertainty: A perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins

(2012) Amy S. Rosenberg et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Affymax poised to challenge Amgen

(2012) Nuala Moran   NATURE BIOTECHNOLOGY

Recombinant immunotoxin engineered for low immunogenicity and antigenicity by identifying and silencing human B-cell epitopes

(2012) W. Liu et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Development of Antidrug Antibodies Against Adalimumab and Association With Disease Activity and Treatment Failure During Long-term Follow-up

(2011) Geertje M. Bartelds   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Development of Immune-Specific Interaction Potentials and Their Application in the Multi-Agent-System VaccImm

(2011) Anna Lena Woelke et al.   PLoS One

Considerations for optimization and validation of an in vitro PBMC derived T cell assay for immunogenicity prediction of biotherapeutics

(2010) Danika Wullner et al.   CLINICAL IMMUNOLOGY

Methods to measure T-cell responses

(2010) Magdalena Plebanski et al.   Expert Review of Vaccines

Biopharmaceutical benchmarks 2010

(2010) Gary Walsh   NATURE BIOTECHNOLOGY

Control systems and decision making for antibody production

(2010) Christopher C Goodnow et al.   NATURE IMMUNOLOGY

ImmunoGrid: towards agent-based simulations of the human immune system at a natural scale

(2010) M. Halling-Brown et al.   PHILOSOPHICAL TRANSACTIONS OF THE ROYAL SOCIETY A-MATHEMATICAL PHYSICAL AND ENGINEERING SCIENCES

Conditional modeling of antibody titers using a zero-inflated poisson random effects model: application to Fabrazyme®

(2009) Peter L. Bonate et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Prediction of immunogenicity: in silico paradigms, ex vivo and in vivo correlates

(2008) A DEGROOT et al.   CURRENT OPINION IN PHARMACOLOGY

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

A Systematic Assessment of MHC Class II Peptide Binding Predictions and Evaluation of a Consensus Approach

(2008) Peng Wang et al.   PLoS Computational Biology