Author:
Jani Darshana,Marsden Robin,Gunsior Michele,Hay Laura Schild,Ward Bethany,Cowan Kyra J.,Azadeh Mitra,Barker Breann,Cao Liching,Closson Kristin R.,Coble Kelly,Dholakiya Sanjay L.,Dusseault Julie,Hays Amanda,Herl Carina,Hodsdon Michael E.,Irvin Susan C.,Kirshner Susan,Kolaitis Gerry,Kulagina Nadia,Kumar Seema,Lai Ching Ha,Lipari Francesco,Liu Susana,Merdek Keith D.,Moldovan Ioana R.,Mozaffari Reza,Pan Luying,Place Corina,Snoeck Veerle,Manning Marta Starcevic,Stocker Dennis,Tary-Lehmann Magdalena,Turner Amy,Vainshtein Inna,Verthelyi Daniela,Williams William T.,Yan Haoheng,Yan Weili,Yang Lili,Yang Lin,Zemo Jennifer,Zhong Zhandong Don
Abstract
AbstractA clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting to facilitate communication of immunogenicity findings and expedient review by industry and health authorities. To address these key bioanalytical reporting gaps and provide a report structure for documenting immunogenicity results, this cross-industry group was formed to establish harmonized recommendations and a develop a submission template to facilitate agency filings. Provided here are recommendations for reporting clinical anti-drug antibody (ADA) assay results using ligand-binding assay technologies. This publication describes the essential bioanalytical report (BAR) elements such as the method, critical reagents and equipment, study samples, results, and data analysis, and provides a template for a suggested structure for the ADA BAR. This publication focuses on the content and presentation of the bioanalytical ADA sample analysis report. The interpretation of immunogenicity data, including the evaluation of the impact of ADA on safety, exposure, and efficacy, is out of scope of this publication.
Graphical Abstract
Publisher
Springer Science and Business Media LLC