Challenges in developing antidrug antibody screening assays
R Dodge, C Daus, D Yaskanin - Bioanalysis, 2009 - Taylor & Francis
Robert Dodge is the Laboratory Director for Immunochemistry and Cell Biology at Taylor
Technology, a Pharmanet company in Princeton, NJ, USA. Taylor Technology is a contract …
Technology, a Pharmanet company in Princeton, NJ, USA. Taylor Technology is a contract …
Cut Points and Performance Characteristics for Anti‐Drug Antibody Assays
V Devanarayan, MG Tovey - Detection and Quantification of …, 2011 - Wiley Online Library
Administration of therapeutic proteins, including recombinant homologues of authentic
human proteins, can result in a loss of immune tolerance, leading to an immune response …
human proteins, can result in a loss of immune tolerance, leading to an immune response …
Anti-drug antibody assay conditions significantly impact assay screen and confirmatory cut-points
B Gorovits, Y Wang, L Zhu, M Araya, J Kamerud… - The AAPS Journal, 2019 - Springer
Assays for the detection and confirmation of anti-drug antibodies (ADA) are commonly used
tools for assessing the immunogenicity of drug candidates in both clinical and nonclinical …
tools for assessing the immunogenicity of drug candidates in both clinical and nonclinical …
Assessing specificity for immunogenicity assays
SJ Swanson, N Chirmule - Bioanalysis, 2009 - Taylor & Francis
Developing sensitive and specific bioanalytical assays for measuring the immunogenicity of
biological therapeutics has become an integral component of the drug-development …
biological therapeutics has become an integral component of the drug-development …
Selection of positive controls and their impact on anti-drug antibody assay performance
JA Weiner, H Natarajan, CJ McIntosh, ES Yang… - Journal of …, 2024 - Elsevier
Abstract Development of assays to reliably identify and characterize anti-drug antibodies
(ADAs) depends on positive control anti-idiotype (anti-id) reagents, which are used to …
(ADAs) depends on positive control anti-idiotype (anti-id) reagents, which are used to …
Drug target interference in immunogenicity assays: recommendations and mitigation strategies
ZD Zhong, A Clements-Egan, B Gorovits, M Maia… - The AAPS Journal, 2017 - Springer
Sensitive and specific methodology is required for the detection and characterization of anti-
drug antibodies (ADAs). High-quality ADA data enables the evaluation of potential impact of …
drug antibodies (ADAs). High-quality ADA data enables the evaluation of potential impact of …
Emerging technologies and generic assays for the detection of anti‐drug antibodies
MA Partridge, S Purushothama… - Journal of immunology …, 2016 - Wiley Online Library
Anti‐drug antibodies induced by biologic therapeutics often impact drug pharmacokinetics,
pharmacodynamics response, clinical efficacy, and patient safety. It is critical to assess the …
pharmacodynamics response, clinical efficacy, and patient safety. It is critical to assess the …
Sensitivity and drug tolerance of antidrug antibody assays in relation to positive control characteristics
D Egging, J Verhagen, K Laat-Arts, B Wit, T Boekel… - Bioanalysis, 2018 - Taylor & Francis
Aim: Detection and characterization of antidrug antibodies (ADA) play a key role in
understanding the relation of ADA with safety and efficacy. Positive controls (PCs) are used …
understanding the relation of ADA with safety and efficacy. Positive controls (PCs) are used …
Generic anti-drug antibody assay with drug tolerance in serum samples from mice exposed to human antibodies
K Stubenrauch, K Mackeben, R Vogel, J Heinrich - Analytical biochemistry, 2012 - Elsevier
Knowledge of the anti-drug antibody (ADA) status is necessary in early research studies.
Because specific assay materials are sparse and time is pressing, a generic assay format …
Because specific assay materials are sparse and time is pressing, a generic assay format …
Affinity capture elution bridging assay: a novel immunoassay format for detection of anti-therapeutic protein antibodies
YQ Chen, TG Pottanat, QL Carter, JS Troutt… - Journal of …, 2016 - Elsevier
Background Increased emphasis on the development of biologics has placed a significant
focus on anti-drug antibody (ADA) detection. To address this need, several immunoassay …
focus on anti-drug antibody (ADA) detection. To address this need, several immunoassay …