From the bench to clinical practice: understanding the challenges and uncertainties in immunogenicity testing for biopharmaceuticals

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

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

(2014) G. Shankar et al.   AAPS Journal

An electrochemiluminescence (ECL)-based assay for the specific detection of anti-drug antibodies of the IgE isotype

(2013) Yuling Wu et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

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

Development and validation of a homogeneous mobility shift assay for the measurement of infliximab and antibodies-to-infliximab levels in patient serum

(2012) Shui-Long Wang et al.   JOURNAL OF IMMUNOLOGICAL METHODS

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

Theoretical Analysis of Interplay of Therapeutic Protein Drug and Circulating Soluble Target: Temporal Profiles of ‘Free’ and ‘Total’ Drug and Target

(2011) Cuyue Tang et al.   PHARMACEUTICAL RESEARCH

Bioanalytical interferences in immunoassays for antibody biotherapeutics

(2011) Charles Pendley et al.   Bioanalysis

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

Anti-infliximab IgE and non-IgE antibodies and induction of infusion-related severe anaphylactic reactions

(2009) A. Vultaggio et al.   ALLERGY

How to systematically evaluate immunogenicity of therapeutic proteins – regulatory considerations

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

Individual medicine in inflammatory bowel disease: Monitoring bioavailability, pharmacokinetics and immunogenicity of anti-tumour necrosis factor-alpha antibodies

(2009) Klaus Bendtzen et al.   SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY

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

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

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

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