Antidrug antibody assay validation: industry survey results.
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.
Gorovits
Boris
B
Wyeth Research, 401 N Middletown Rd., Pearl River, New York 10965, USA. gorovib@wyeth.com
D000906:Antibodies / Q000032:analysis* / Q000276:immunology; D000915:Antibody Affinity; D000918:Antibody Specificity; D000937:Antigen-Antibody Reactions; D001667:Binding, Competitive; D001688:Biological Products / Q000276:immunology*; D002138:Calibration; D003625:Data Collection; D004345:Drug Industry; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards / Q000706:statistics & numerical data; D006801:Humans; D007753:Laboratories / Q000706:statistics & numerical data; D008163:Luminescent Measurements / Q000706:statistics & numerical data; D004364:Pharmaceutical Preparations; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012957:Societies, Pharmaceutical; D018709:Statistics, Nonparametric; D054928:Validation Studies as Topic
D000906:Antibodies; D001688:Biological Products; D004364:Pharmaceutical Preparations