Neutralizing Antibody Sample Testing and Report Harmonization.

IF 5 3区医学 Q1 PHARMACOLOGY & PHARMACY

AAPS Journal Pub Date : 2024-07-12 DOI:10.1208/s12248-024-00955-1

Darshana Jani, Michele Gunsior, Robin Marsden, Kyra J Cowan, Susan C Irvin, Laura Schild Hay, Bethany Ward, Luke Armstrong, Mitra Azadeh, Liching Cao, Rebecca Carmean, Jason DelCarpini, Sanjay L Dholakiya, Amanda Hays, Sarah Hosback, Zheng Hu, Nadia Kulagina, Seema Kumar, Ching Ha Lai, Marit Lichtfuss, Hsing-Yin Liu, Susana Liu, Reza Mozaffari, Luying Pan, Jason Pennucci, Marie-Eve Poupart, Gurleen Saini, Veerle Snoeck, Kristine Storey, Amy Turner, Inna Vainshtein, Daniela Verthelyi, Iwona Wala, Lili Yang, Lin Yang

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引用次数: 0

Abstract

Immunogenicity testing and characterization is an important part of understanding the immune response to administration of a protein therapeutic. Neutralizing antibody (NAb) assays are used to characterize a positive anti-drug antibody (ADA) response. Harmonization of reporting of NAb assay performance and results enables efficient communication and expedient review by industry and health authorities. Herein, a cross-industry group of NAb assay experts have harmonized NAb assay reporting recommendations and provided a bioanalytical report (BAR) submission editable template developed to facilitate agency filings. This document addresses key bioanalytical reporting gaps and provides a report structure for documenting clinical NAb assay performance and results. This publication focuses on the content and presentation of the NAb sample analysis report including essential elements such as the method, critical reagents and equipment, data analysis, study samples, and results. The interpretation of immunogenicity data, including the evaluation of the impact of NAb on safety, exposure, and efficacy, is out of scope of this publication.

Abstract Image

查看原文本刊更多论文

中和抗体样本检测与报告协调。

免疫原性测试和特征描述是了解服用蛋白质疗法后免疫反应的重要部分。中和抗体（NAb）测定用于描述阳性抗药抗体（ADA）反应。对 NAb 检测性能和结果的报告进行统一，可使业界和卫生当局进行有效沟通和快速审查。在此，一个由 NAb 检测专家组成的跨行业小组对 NAb 检测报告建议进行了统一，并提供了一个生物分析报告 (BAR) 提交可编辑模板，以方便机构备案。该文件弥补了生物分析报告的主要不足，并提供了记录临床 NAb 检测性能和结果的报告结构。本出版物重点介绍 NAb 样品分析报告的内容和表述方式，包括方法、关键试剂和设备、数据分析、研究样本和结果等基本要素。免疫原性数据的解释，包括 NAb 对安全性、暴露和疗效影响的评估，不在本出版物的讨论范围之内。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

AAPS Journal 医学-药学

CiteScore

7.80

自引率

4.40%

发文量

109

审稿时长

1 months

期刊介绍： The AAPS Journal, an official journal of the American Association of Pharmaceutical Scientists (AAPS), publishes novel and significant findings in the various areas of pharmaceutical sciences impacting human and veterinary therapeutics, including: · Drug Design and Discovery · Pharmaceutical Biotechnology · Biopharmaceutics, Formulation, and Drug Delivery · Metabolism and Transport · Pharmacokinetics, Pharmacodynamics, and Pharmacometrics · Translational Research · Clinical Evaluations and Therapeutic Outcomes · Regulatory Science We invite submissions under the following article types: · Original Research Articles · Reviews and Mini-reviews · White Papers, Commentaries, and Editorials · Meeting Reports · Brief/Technical Reports and Rapid Communications · Regulatory Notes · Tutorials · Protocols in the Pharmaceutical Sciences In addition, The AAPS Journal publishes themes, organized by guest editors, which are focused on particular areas of current interest to our field.