一个强大的质量基础设施是安全和有效的免疫效应细胞输送的关键:如何FACT查找可以帮助
Kevin J Curran1, Sarah Nikiforow2, Carlos Bachier3
1Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
免疫效应细胞 (IEC) 疗法为各种疾病提供了变革的潜力. 这项研究概述了"细胞治疗认证基金会" (Foundation for the Accreditation of Cellular Therapy) 的工作.
科学领域:
- 细胞疗法和免疫疗法.
- 医疗创新和医疗保健系统
背景情况:
- 免疫效应细胞 (IEC) 越来越多地用于恶性和非恶性疾病.
- IEC产品的扩展需要强大的机构工作流程,以确保安全实施.
- 由于不同的目标,疾病,来源和毒性,IEC疗法存在复杂性.
研究的目的:
- 概述目前免疫效应细胞 (IEC) 计划开发和认证的现状.
- 确定并提出解决IEC治疗机构所面临的挑战的解决方案.
- 支持安全有效地扩展新型IEC疗法.
主要方法:
- 审查IEC程序开发的当前情景.
- 分析了由细胞疗法认证基金会 (FACT) 制定的认证标准.
- 识别IEC治疗的挑战和建议解决方案.
主要成果:
- IEC治疗需要相当大的机构带宽和基础设施.
- 细胞疗法认证基金会 (FACT) 为IEC产品制定了标准,包括CAR-T细胞.
- FACT已经建立了一个程序框架,以加强IEC治疗的交付.
结论:
- 机构必须制定全面的工作流程,以安全地提供IEC疗法.
- 认证标准对于确保IEC产品的质量和安全至关重要.
- 解决基础设施和带宽挑战是扩展新型IEC疗法的关键.
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