The method history report: an adaptable tool for communicating immunogenicity assay development and validation

Over the developmental lifetime of a therapeutic protein, the immunogenicity assay validation history can become substantial, frustrating review of clinical immunogenicity within the biologics license application. In our experience, this can lead to questions by regulators, resulting in numerous inf...

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Published in:Bioanalysis 2020-11, Vol.12 (22), p.1597-1605
Main Authors: Hollister, Kristin, Nguyen, Huy T, Bishop, Jessie L, Cramer, Jeff W, Bivi, Nicoletta, Gardner, Margaret A, Konrad, Robert J, Hodsdon, Michael E
Format: Article
Language:English
Subjects:
biologics license application
Clinical trials
Corporate sponsorship
Immunogenicity
immunogenicity assay
Ligands
regulatory interactions
Validation studies
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container_end_page 1605
container_issue 22
container_start_page 1597
container_title Bioanalysis
container_volume 12
creator Hollister, Kristin
Nguyen, Huy T
Bishop, Jessie L
Cramer, Jeff W
Bivi, Nicoletta
Gardner, Margaret A
Konrad, Robert J
Hodsdon, Michael E
description Over the developmental lifetime of a therapeutic protein, the immunogenicity assay validation history can become substantial, frustrating review of clinical immunogenicity within the biologics license application. In our experience, this can lead to questions by regulators, resulting in numerous information requests during the review process. To address this, we propose a new document, the method history report (MHR), which can comprehensively present the history of the immunogenicity assay for regulators, including assay development and validation. The flexibility of the MHR allows for adaptation to the specific needs of each therapeutic program, while maintaining a consistent template. Here, we detail the rationale, general outline and template for the MHR and recommend others consider adopting it for their biologics license application-related activities.
doi_str_mv 10.4155/bio-2020-0234
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subjects biologics license application
Clinical trials
Corporate sponsorship
Immunogenicity
immunogenicity assay
Ligands
regulatory interactions
Validation studies
title The method history report: an adaptable tool for communicating immunogenicity assay development and validation
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