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. 2022 Oct 28;24(6):113.
doi: 10.1208/s12248-022-00762-6.

Anti-drug Antibody Sample Testing and Reporting Harmonization

Darshana Jani  1 , Robin Marsden  2 , Michele Gunsior  3 , Laura Schild Hay  4 , Bethany Ward  4 , Kyra J Cowan  5 , Mitra Azadeh  6 , Breann Barker  7 , Liching Cao  8 , Kristin R Closson  9 , Kelly Coble  10 , Sanjay L Dholakiya  11 , Julie Dusseault  12 , Amanda Hays  13 , Carina Herl  14 , Michael E Hodsdon  15 , Susan C Irvin  16 , Susan Kirshner  17 , Gerry Kolaitis  11 , Nadia Kulagina  18 , Seema Kumar  19 , Ching Ha Lai  16 , Francesco Lipari  20 , Susana Liu  21 , Keith D Merdek  22 , Ioana R Moldovan  23 , Reza Mozaffari  24 , Luying Pan  25 , Corina Place  10 , Veerle Snoeck  26 , Marta Starcevic Manning  27 , Dennis Stocker  11 , Magdalena Tary-Lehmann  28 , Amy Turner  18 , Inna Vainshtein  14 , Daniela Verthelyi  17 , William T Williams  29 , Haoheng Yan  17 , Weili Yan  30 , Lili Yang  25 , Lin Yang  31 , Jennifer Zemo  29 , Zhandong Don Zhong  32
Affiliations

Anti-drug Antibody Sample Testing and Reporting Harmonization

Darshana Jani et al. AAPS J. .

Abstract

A 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.

Keywords: Anti-drug antibodies (ADA); Bioanalytical report (BAR); Clinical Study Report (CSR); Immunogenicity; In-study cut point; Report harmonization; The Integrated Summary of Immunogenicity (ISI).

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References

    1. Myler H, Pedras-Vasconcelos J, Phillips K, et al. Anti-drug antibody validation testing and reporting harmonization. AAPS J. 2021;24(1):4. https://doi.org/10.1208/s12248-021-00649-y . - DOI - PubMed
    1. EMA. Guideline on immunogenicity assessment of therapeutic proteins. In: (CHMP) CfMPfHU, editor. London. 2017.
    1. Mire-Sluis AR, et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods. 2004;289(1-2):1–16. https://doi.org/10.1016/j.jim.2004.06.002 . - DOI - PubMed
    1. Chamberlain P. Effective presentation of immunogenicity risk assessments and related data in regulatory dossiers. Bioanalysis. 2019;11(17):1581–92. https://doi.org/10.4155/bio-2018-0209 . - DOI - PubMed
    1. Immunogenicity testing of therapeutic protein products —developing and validating assays for anti-drug antibody detection, guidance for industry. In: U.S. FDA CfDEaR, Center for Biologics Evaluation and Research, editor. MD, USA. 2019.

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