Antidrug Antibody Assay Validation: Industry Survey Results

Overview

Journal AAPS J

Specialty Pharmacology

Date 2009 Mar 4

PMID 19255857

Citations 12

Authors

Boris Gorovits

Affiliations

Soon will be listed here.

Abstract

Immunogenicity of biopharmaceutical products has attracted considerable attention from the industrial, academia, and regulatory organizations. Many methods exist to detect and characterize level of antidrug antibody response in patients. Still, additional work is required to harmonize various approaches used throughout the industry. This review presents results of a survey sponsored by the American Association of Pharmaceutical Scientists that was designed to collect relevant information and to understand various methods used throughout the bioanalytical field for the detection and evaluation of antidrug antibody responses.

Citing Articles

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Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays.

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