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细胞疗法现场准备:在大型学术医疗中心的住院药房实施

Janine G Martino¹, Kim McConnell², Lorraine Greathouse³

¹Department of Pharmacy, UC San Diego Health, Jacobs Medical Center, La Jolla, USA.

Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners

|August 28, 2024

概括

随着FDA的批准,现在可以在药房准备细胞疗法. 这个过程需要多学科的合作来验证FACT,确保安全有效的无菌复合和管理这些关键产品.

科学领域:

制药科学制药科学
细胞疗法细胞疗法
监管事务监管事务

背景情况:

由于短时间的稳定性和产品操纵要求,FDA对细胞疗法的批准需要当地药房的准备.
这一转变需要评估监管标准,修订标准操作程序,验证流程,并解决安全和培训需求.

研究的目的:

详细说明基于药房的细胞疗法无菌化合物的FACT验证和安装过程.
提供关于建立安全和高效的工作流程来处理这些产品的见解.

主要方法:

监管标准和职业安全的评估.
标准运营程序和政策的修订.
发展员工培训和教育计划.
无菌操作的正式过程验证.

主要成果:

当地药房制剂的实施使细胞疗法的有效无菌操纵成为可能.
多学科的方法对于成功的FACT认证和计划实施至关重要.

结论:

药剂师主导的细胞疗法的无菌合成需要协调,多学科的努力.
当地准备提高了运营工作流程,并确保安全,高效的无菌操作.

关键词:

细胞疗法是一种细胞疗法.通过FACT验证验证.住院药房住院药房住院药房利索卡巴塔基因马拉利乌塞尔无菌的复合物复合物

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