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Cytokine release assays: Current practices and future directions

机译：细胞因子释放测定：当前的实践和未来方向

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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超大中的生物治疗性单克隆抗体（TGN 1412）“细胞因子风暴”事件，细胞因子释放测定（CRA）已成为危害识别和前瞻性风险评估工具，用于筛查针对具有潜在风险的新型生物治疗方法具有潜在风险的促销欠普利专业 - 炎症性临床输注反应。不同的实验室可能具有不同的策略，测定格式和报告，解释和使用数据的方法，以获取决策或风险评估的数据。此外，许多独立合同研究组织（CROS），学术和政府实验室都参与了CRA工作的某些方面。因此，一些制药公司在必要时提供CRA数据作为监管提交的一部分，技术和监管实践仍在不断发展，以提供人类细胞因子释放的数据，与安全相关。本手稿概述了制药行业和CRO的不同方法，用于基于ILSI-Health和环境科学研究所（HESI）ImmunoTox-Icology Charm CRA工作的调查和调查后续调查团体。还讨论了学术界，监管环境，测定的当前限制以及细胞因子释放测定的未来方向和建议的持续研究。

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