先进疗法的新挑战 先进疗法的新挑战
Juan Eduardo Megías-Vericat1, Ana Bonora-Centelles A2, Tomás Palanques-Pastor1
1Servicio de Farmacia, Área del Medicamento, Hospital Universitari i Politècnic La Fe, Valencia, España; Unidad de Terapias Avanzadas, Instituto Investigación Sanitaria La Fe, Valencia, España.
在医院中实施先进治疗单元 (AUT) 确保先进治疗药品 (ATMP) 的质量. 这个部门支持研究,并促进患者获得新的治疗方法,如病毒特异性T细胞 (VSTs).
科学领域:
- 细胞疗法是一种细胞疗法.
- 药理学 药理学是指药理学的学科.
- 医院药房 医院药房 医院药房
背景情况:
- 先进治疗药物 (ATMP) 正在迅速发展,这给医院药房带来了挑战.
- 医院药房必须适应这些复杂疗法的生产和质量控制.
- 对ATMP的学术生产需要特定的基础设施和专业知识.
研究的目的:
- 描述一个先进疗法单元 (AUT) 的实施.
- 详细说明在"良好制造实践" (GMP) 下准备ATMP的过程.
- 展示在第三级医院的学术ATMP生产的结果.
主要方法:
- 建立一个符合GMP要求的AUT.
- 组建一个训练有素的GMP多学科团队.
- 为VST准备和管理开发一个协作电路.
主要成果:
- 该AUT确保ATMP的质量,并支持研究.
- 该单位已获准用于五种类型的异性病毒特异性T细胞 (VSTs).
- 一个协作电路使VST治疗移植后的病毒再激活成为可能.
结论:
- 初步结果表明VST是有效和安全的.
- 通过"医院豁免"的医院生产可以改善早期获得孤儿ATMP的机会.
- 医院药剂师对良好的医疗惯例的培训对于ATMP的开发和监管合规性至关重要.
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