Bioanalytical and Molecular Assays, Moderna, 325 Binney Street, Cambridge, Massachusetts, USA.
Translational Sciences, Astria Therapeutics, Boston, Massachusetts, USA.
AAPS J. 2024 Jul 12;26(4):80. doi: 10.1208/s12248-024-00955-1.
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.
免疫原性检测和特征分析是了解蛋白治疗药物给药后免疫反应的重要组成部分。中和抗体 (NAb) 检测用于分析阳性抗药物抗体 (ADA) 反应。NAb 检测性能和结果报告的协调统一有助于行业和卫生当局之间进行高效沟通和快速审查。在此，一个跨行业的 NAb 检测专家小组对 NAb 检测报告建议进行了协调，并提供了一个可编辑的生物分析报告 (BAR) 提交模板，以方便机构提交文件。本文档解决了关键的生物分析报告空白，并为记录临床 NAb 检测性能和结果提供了报告结构。本出版物重点介绍了 NAb 样品分析报告的内容和呈现方式，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、暴露和疗效的影响评估，不在本出版物的范围内。
