Antidrug Antibody Assay Validation: Industry Survey Results
Journal Title: The AAPS Journal - Year 2009, Vol 11, Issue 1
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.
Authors and Affiliations
Boris Gorovits
Keywords
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