[翻译文章]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, Spain; Unidad de Terapias Avanzadas, Instituto Investigación Sanitaria La Fe, Valencia, Spain.
概括
医院药房面临着先进治疗药物 (AMTP) 的挑战. 实施先进疗法单元 (AUT) 确保了准备这些复杂的细胞疗法,如病毒特异性T细胞 (VST) 的GMP合规性,为移植患者提供了安全的替代方案.
科学领域:
- 药理学和制药科学 药理学和制药科学
- 细胞和分子医学是细胞和分子医学.
- 血液学 血液学 血液学
背景情况:
- 先进疗法药物 (AMTP) 正在迅速发展,这给医院药房业务带来了重大挑战.
- 医院药房必须适应复杂的后勤和监管要求,为商业和研究目的准备AMTP.
研究的目的:
- 描述在第三级医院内实施先进治疗单元 (AUT) 的情况.
- 详细说明准备AMTP的过程,遵守良好的制造实践 (GMP).
- 介绍AMTP生产的成果,重点关注学术生产的挑战.
主要方法:
- 建立符合GMP标准的AUT,以确保产品质量和安全.
- 组建一个经过良好的医疗惯例培训的多学科团队,用于制备特定的AMTP,包括全基病毒特异性T细胞 (VST).
- 开发一个合作电路,涉及AUT,药房和血液学服务,用于VST临床应用和准备.
主要成果:
- 该AUT成功满足了GMP要求,保证了制备的药物的质量.
- 建立的电路有助于使用VST治疗血造干细胞移植患者的治疗,这些患者具有抗性病毒活性.
- 初步数据表明,VST是特定患者群体的有效和安全的治疗选择.
结论:
- 学术AMTPs,特别是孤儿指示,可以通过"医院豁免"从医院生产中受益,以获得更早,更具成本效益的访问.
- 对医院药剂师进行良好的医疗惯例培训对于开发符合物流和监管标准的AMTP至关重要.
- 该AUT模型为医院药房提供了一个框架,以管理先进治疗药品制备和支持研究的复杂性.
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