CELL & GENE THERAPY INSIGHTS AUTOMATION: MIGRATION FROM MANUAL PROCESSES TO CLOSED-SYSTEM AUTOMATION Automating decentralized manufacturing of cell and gene therapy products
CELL & GENE THERAPY INSIGHTS AUTOMATION: MIGRATION FROM MANUAL PROCESSES TO CLOSED-SYSTEM AUTOMATION Automating decentralized manufacturing of cell and gene therapy products
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细胞
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通讯作者：
L. Gilbert
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作者：
D. Lester;L. Gilbert
分散或重新分配的制造可能是某些基于细胞和基因的疗法，特别是个性化疗法的首选制造方法。这种方法最终将取决于商业模式，并将考虑到监管和供应链因素。技术的进步和自动化生产平台的整合已经证明了分散制造的潜力，但是需要将自动化的范围扩展到整个过程，包括细胞分离，分配，跟踪，管理，质量管理系统和自动化分析技术的开发，以促进实时发布。为了将分散式制造成功地整合到细胞和基因治疗生产中，其他公认的医疗保健相关制造模式的经验教训可以为做出明智的决策提供有用的见解和观点。此类模型与分散式生产具有相似的特征，因为它们是患者特异性的，并且具有有限的艾德给药时间范围。这些现有的方法已经成功地结合了自动化的各个方面，可以为成功提供蓝图，并可能加快患者特异性细胞和基因治疗制造的分散化。
Decentralized, or redistributed manufacture, is likely to be the manufacturing approach of choice for some cell- and gene-based therapies, in particular, personalized therapies. Such an approach will ultimately depend on the business model and will take into account the regulatory and supply chain factors. Advances in technology and integration of automated production platforms have demonstrated the potential for decentralized manufacturing, however there is a need to extend the scope of automation across the entire process including the cell isolation, distribution, tracking, administration, quality management systems and development of automated analytical techniques to facilitate real-time release. For decentralized manufacture to be successfully integrated for cell and gene therapy production, lessons from other accepted healthcare-associated models of manufacture can provide useful insights and perspectives to make informed decisions. Such models share similar characteristics to decentralized manufacture in that they are patient-specific and have a limit ed time-frame for administration. These existing approaches, which have successfully incorporated aspects of automation, can provide a blueprint for success and may expedite the decentralization of patient-specific cell and gene therapy manufacture.