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Article
An Antibody-Dependent Cellular Cytotoxicity Assay for Detecting Ocrelizumab Neutralizing Antibody
Ocrelizumab (OCREVUS®) is a humanized anti-CD20 monoclonal antibody approved for the treatment of adult patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Here,...
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Article
Open AccessNeutralizing Antibody Validation Testing and Reporting Harmonization
Evolving immunogenicity assay performance expectations and a lack of harmonized neutralizing antibody validation testing and reporting tools have resulted in significant time spent by health authorities and sp...
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Article
Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development
A survey conducted by the Therapeutic Product Immunogenicity (TPI) community within the American Association of Pharmaceutical Scientists (AAPS) posed questions to the participants on their immunogenicity risk...
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Article
Correction to: Preclinical development of ZED8, an 89Zr immuno‑PET reagent for monitoring tumor CD8 status in patients undergoing cancer immunotherapy
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Article
Preclinical development of ZED8, an 89Zr immuno-PET reagent for monitoring tumor CD8 status in patients undergoing cancer immunotherapy
ZED8 is a novel monovalent antibody labeled with zirconium-89 for the molecular imaging of CD8. This work describes nonclinical studies performed in part to provide rationale for and to inform expectations in ...
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Protocol
Method for Measurement of Antibody-Dependent Cellular Phagocytosis
Antibody-based therapeutics are powerful tools to treat disease. While their mechanism of action (MOA) always involves binding to a specific target via the antibody-binding fragment (Fab) region of the antibod...
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Protocol
Methods for Functional Characterization of FcRn Interactions with Therapeutic Antibodies and Fc-Fusion Proteins
The neonatal Fc receptor (FcRn) plays a key role in determining the pharmacokinetic behavior of therapeutic monoclonal antibodies (mAbs). FcRn-mediated intracellular trafficking mechanisms extend the half-live...
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Chapter
Monoclonal Antibodies: From Structure to Therapeutic Application
The exciting field of therapeutic monoclonal antibodies (MABs) had its origins when Köhler and Milstein presented their murine hybridoma technology in 1975. This technology provides a reproducible method for p...
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Article
Strategies to Determine Assay Format for the Assessment of Neutralizing Antibody Responses to Biotherapeutics
Most biotherapeutics can elicit immune responses in dosed recipients generating anti-drug antibodies (ADAs). Neutralizing antibodies (NAbs) are a subpopulation of ADAs that can potentially impact patient safet...
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Article
Advances in the assessment and control of the effector functions of therapeutic antibodies
The Fc (crystallizable fragment) region of therapeutic antibodies can have an important role in their safety and efficacy. This article summarizes the current knowledge of antibody Fc functionality, provides a...
