Recommendations for the development and validation of confirmatory anti-drug antibody assays

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

(2014) G. Shankar et al.   AAPS Journal

Addressing matrix effects in ligand-binding assays through the use of new reagents and technology

(2014) Shannon D Chilewski et al.   Bioanalysis

Protein-based matrix interferences in ligand-binding assays

(2014) Boris Gorovits et al.   Bioanalysis

Statistical and Bioanalytical Considerations for Establishing a Depletion Criterion for Specificity Testing During Immunogenicity Assessment of a Biotherapeutic

(2013) R. O. Driscoll et al.   AAPS Journal

Altering drug tolerance of surface plasmon resonance assays for the detection of anti-drug antibodies

(2013) Maria D.F.S. Barbosa et al.   ANALYTICAL BIOCHEMISTRY

Novel data analysis methods to overcome cut point challenges and enable comprehensive assessment of antidrug binding activity in confirmatory assays

(2013) Alvydas Mikulskis et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Regarding confirmatory immunogenicity assays

(2013) Daniel Coleman et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Ligand Binding Assays in the 21st Century Laboratory: Recommendations for Characterization and Supply of Critical Reagents

(2012) Denise M. O’Hara et al.   AAPS Journal

Addressing drug effects on cut point determination for an anti-drug antibody assay

(2012) Maria D.F.S. Barbosa et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Correlation of screening and confirmatory results in tiered immunogenicity testing by solution-phase bridging assays

(2012) Robert J. Kubiak et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Strategic selection and development of immunogenicity binding methods

(2012) Ana T Menendez   Bioanalysis

Summary of Confirmation Cut Point Discussions

(2011) Holly W. Smith et al.   AAPS Journal

Implementation of design of experiments (DOE) in the development and validation of a cell-based bioassay for the detection of anti-drug neutralizing antibodies in human serum

(2011) Xinyi C. Chen et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Identification and inhibition of drug target interference in immunogenicity assays

(2010) Zhandong D. Zhong et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Comparing Exponentially Weighted Moving Average and Run Rules in Process Control of Semiquantitative Immunogenicity Immunoassays

(2009) Troy E. Barger et al.   AAPS Journal

Assessing specificity for immunogenicity assays

(2009) Steven J Swanson et al.   Bioanalysis

Development, Validation, and Clinical Implementation of an Assay to Measure Total Antibody Response to Naglazyme® (Galsulfase)

(2008) Joleen T. White et al.   AAPS Journal

Complexities of Clinical Assay Development and Optimization Prior to First-in-Man Immunization Trials – A Description of Immunogenicity Assay Development for the Testing of Samples from a Phase 1 Alzheimer's Vaccine Trial

(2008) Olivia Hammond et al.   JOURNAL OF IMMUNOASSAY & IMMUNOCHEMISTRY

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

Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins

(2008) Chad A. Ray et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

The development and validation of a sensitive, dual-flow cell, SPR-based biosensor immunoassay for the detection, semi-quantitation, and characterization of antibodies to darbepoetin alfa and epoetin alfa in human serum

(2008) Daniel T. Mytych et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS