个性化医疗通过为每位患者提供量身定制的治疗方案,具有改变医疗保健的巨大潜力,但其制造过程面临明显挑战。要克服这些障碍,需要一套特定的解决方案。通过应对这些挑战,个性化医疗的制造过程将更加简化,能够为患者快速提供有针对性且有效的治疗,从而显著提升患者的治疗效果。
ATMP 之旅
每年,ATMP 试验带来超过 USD23000000000 的投资。强大的技术基础和灵活的解决方案是确保专利独占性、将运营扩展到临床试验以及加速产品上市的关键。ATMP 之旅分为三大类:基因疗法、体细胞疗法和组织工程药物,未来的重点在于实施敏捷且灵活的系统,以便在快速变化的环境中实现快速适应和可扩展性。
临床前
临床试验和监管审查
商业生产
影响 ATMP 之旅的关键挑战
数据管理与上市时间
由于人工操作、缺乏合格的自动化、生产线和产品切换效率低下,以及无法实现数字化技术转移,实时发布受到阻碍。
流程复杂性与扩展
由于SKU数量增加且批次规模较小,扩展工作成本高昂。ATMP制造的复杂性进一步加剧了这些问题。
员工队伍效能
对部落知识的依赖阻碍了关键技能的传播,并加剧了手动活动的运营风险。
法规合规性
分散且无序的数据阻碍了与监管机构的协同,影响产品质量和报告,从而影响运营权。
通过全面的数字化转型战略克服挑战
数字化使新技术和新理念能够以更低的成本、更快的速度进行测试,这在以往是难以实现的。利用促进个性化药物开发领域灵活、可扩展制造的新技术。
Check this out from Rockwell Automation. I thought you'd find it interesting:
深入了解高级治疗药物产品
ATMP 处于个性化医疗的前沿。让我们通过创新的解决方案帮助您轻松应对挑战。
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视频
Testa Center and Cytiva
Testa Center and Cytiva
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Advanced Therapies Solutions
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Transforming CGT Manufacturing
Transforming CGT Manufacturing
From drug discovery to commercial production, advances in digitization and automation provide solutions to the toughest of challenges.
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