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Cytokine release assays: Current practices and future directions

机译：细胞因子释放测定：当前实践和未来方向

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摘要

As a result of the CD28 superagonist biotherapeutic monoclonal antibody (TGN 1412) "cytokine storm" incident, cytokine release assays (CRA) have become hazard identification and prospective risk assessment tools for screening novel biotherapeutics directed against targets having a potential risk for eliciting adverse pro-inflammatory clinical infusion reactions. Different laboratories may have different strategies, assay formats, and approaches to the reporting, interpretation, and use of data for either decision making or risk assessment. Additionally, many independent contract research organizations (CROs), academic and government laboratories are involved in some aspect of CRA work. As a result, while some pharmaceutical companies are providing CRA data as part of the regulatory submissions when necessary, technical and regulatory practices are still evolving to provide data predictive of cytokine release in humans and that are relevant to safety. This manuscript provides an overview of different approaches employed by the pharmaceutical industry and CROs, for the use and application of CRA based upon a survey and post survey follow up conducted by ILSI-Health and Environmental Sciences Institute (HESI) Immunotox-icology Committee CRA Working Group. Also discussed is ongoing research in the academic sector, the regulatory environment, current limitations of the assays, and future directions and recommendations for cytokine release assays.
机译：由于CD28超激动剂生物治疗性单克隆抗体（TGN 1412）“细胞因子风暴”事件的发生，细胞因子释放测定法（CRA）已成为危害识别和前瞻性风险评估工具，用于筛选针对潜在具有引起不良前瞻性潜在风险的靶标的新型生物治疗剂-临床炎症反应。不同的实验室可能具有不同的策略，化验格式以及报告，解释和将数据用于决策或风险评估的方法。此外，许多独立的合同研究组织（CRO），学术和政府实验室也参与CRA工作的某些方面。结果，尽管一些制药公司在必要时将CRA数据作为监管文件的一部分提供，但技术和监管惯例仍在不断发展，以提供可预测人体内细胞因子释放且与安全性相关的数据。该手稿基于ILSI-健康与环境科学研究所（HESI）免疫毒素学委员会CRA工作进行的调查和事后调查，概述了制药行业和CRO使用和应用CRA的不同方法。组。还讨论了学术领域的持续研究，监管环境，测定的当前局限性以及细胞因子释放测定的未来方向和建议。

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