Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
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DOI：
10.1016/j.jim.2004.06.002
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发表时间：
2004-06-01
影响因子：
2.2
通讯作者：
Zuckerman, LA
中科院分区：
文献类型：
--
作者：
Mire-Sluis, AR;Barrett, YC;Zuckerman, LA
大多数生物制药治疗剂引起针对产品的一定水平的抗体应答。在某些情况下，这种抗体应答可能导致潜在的严重副作用和/或功效丧失。因此，治疗性蛋白质的免疫原性是临床医生、制造商和监管机构关注的问题。为了评估这些分子的免疫原性，需要对抗体应答进行适当的检测、定量和表征。设计不当的抗体检测试剂盒已导致产品开发受阻，或在许可期间，上市后承诺受阻。本文件根据作者的经验提供了用于临床前或临床研究的抗产品抗体免疫测定开发的科学建议。虽然本文件的主要重点是分析设计考虑因素，但我们提供了开发有效分析所需的各种分析性能参数的科学重点和背景。本手稿中包含有关检测试剂盒性能参数的章节，包括监管指南中出现的参数。(C)2004 Elsevier B. V.保留所有权利。
Most biopharmaceutical therapeutics elicit some level of antibody response against the product. This antibody response can, in some cases, lead to potentially serious side effects and/or loss of efficacy. Therefore, the immunogenicity of therapeutic proteins is a concern for clinicians, manufacturers and regulatory agencies. In order to assess immunogenicity of these molecules, appropriate detection, quantitation and characterization of antibody responses are necessary. Inadequately designed antibody assays have led to the hampering of product development or, during licensure, post-marketing commitments. This document provides scientific recommendations based on the experience of the authors for the development of anti-product antibody immunoassays intended for preclinical or clinical studies. While the main focus of this document is assay design considerations, we provide scientific focus and background to the various assay performance parameters necessary for developing a valid assay. Sections on assay performance parameters, including those that appear in regulatory guidances, are contained in this manuscript. (C) 2004 Elsevier B.V. All rights reserved.