Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

Development of a Method That Eliminates False-Positive Results due to Nerve Growth Factor Interference in the Assessment of Fulranumab Immunogenicity

(2014) Sheng Dai et al.   AAPS Journal

Theoretical Considerations and Practical Approaches to Address the Effect of Anti-drug Antibody (ADA) on Quantification of Biotherapeutics in Circulation

(2013) Marian Kelley et al.   AAPS Journal

Immunogenicity to Therapeutic Proteins: Impact on PK/PD and Efficacy

(2012) Narendra Chirmule et al.   AAPS Journal

A Survey of Applications of Biological Products for Drug Interference of Immunogenicity Assays

(2012) Yow-Ming C. Wang et al.   PHARMACEUTICAL RESEARCH

Assessing Response and Loss of Response to Biological Therapies in IBD

(2011) Henit Yanai et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

Venous and arterial thromboembolic events in adalimumab-treated patients with antiadalimumab antibodies: A case series and cohort study

(2011) L. A. Korswagen et al.   ARTHRITIS AND RHEUMATISM

Taking immunogenicity assessment of therapeutic proteins to the next level

(2011) I.C. Büttel et al.   BIOLOGICALS

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

Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics

(2011) Shalini Gupta et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatic diseases

(2011) Emilie Ducourau et al.   ARTHRITIS RESEARCH & THERAPY

Dealing with immunogenicity of biologicals: assessment and clinical relevance

(2010) Gerrit J Wolbink et al.   CURRENT OPINION IN RHEUMATOLOGY

Detection of low-affinity anti-drug antibodies and improved drug tolerance in immunogenicity testing by Octet® biolayer interferometry

(2010) Jian Li et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Cut-off levels and diagnostic accuracy of infliximab trough levels and anti-infliximab antibodies in Crohn's disease

(2010) Casper Steenholdt et al.   SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY

How to systematically evaluate immunogenicity of therapeutic proteins – regulatory considerations

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

Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies

(2009) Rafael Ponce et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products

(2008) Eugen Koren et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products

(2008) Gopi Shankar et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS