How do I structure logistic processes in preparation for outsourcing of cellular therapy manufacturing?
How do I structure logistic processes in preparation for outsourcing of cellular therapy manufacturing?
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DOI：
10.1111/trf.15349
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发表时间：
2019-08-01
期刊：
影响因子：
2.9
通讯作者：
Panch, Sandhya R.
中科院分区：
文献类型：
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作者：
Chen, Leonard N.;Collins-Johnson, Naoza;Panch, Sandhya R.
随着细胞和基因疗法（CGT）在几种急性和慢性疾病的早期临床试验中占据中心地位，人们对生产过程的标准化和自动化产生了浓厚的兴趣，为商业化做准备。为了实现这一目标，一种混合的、通常在地理上分开的模式，包括区域性细胞采购和输注设施以及集中式细胞制造单元，正在该领域获得关注。虽然学术机构的CGT处理设施不直接参与这些疗法的生产，但他们必须准备好与商业或合同生产组织（CMO）合作，并准备好应对自体和同种异体CGT出现的几个供应链挑战。学术中心的细胞处理设施必须处理许多生产上游和下游的事件，如供体筛选、细胞收集、产品标签、冷冻保存、运输和解冻输注。这些事件值得在多设施生产的背景下进行更密切的评价，因为标准程序尚未建立。根据我们的机构经验，我们总结了在早期研究中CGT产品的处理和分销中遇到的物流挑战，特别是涉及CMO（外包）制造的挑战。我们还建议将CGT供应链特有的流程标准化，强调需要保持从产品采集到输注的针头到针头的可追溯性。这些指南将为更大规模细胞和基因治疗的更复杂供应链模型的开发提供信息。
As cell and gene therapies (CGT) assume center stage in early-phase clinical trials for several acute and chronic diseases, there is heightened interest in the standardization and automation of manufacturing processes in preparation for commercialization. Toward this goal, a hybrid and oftentimes geographically separated model comprising regional cell procurement and infusion facilities and a centralized cell manufacturing unit is gaining traction in the field. Although CGT processing facilities in academic institutions are not involved directly in the manufacturing of these therapies, they must be prepared to collaborate with commercial or contract manufacturing organizations (CMOs) and be ready to address several supply-chain challenges that have emerged for autologous and allogeneic CGT. Academic center cell-processing facilities must handle many events up- and downstream of manufacturing such as donor screening, cell collection, product labeling, cryopreservation, transportation, and thaw infusion. These events merit closer evaluation in the context of multifacility manufacturing since standard procedures have yet to be established. Based on our institutional experience, we summarize logistical challenges encountered in the handling and distribution of CGT products in early phase studies, specifically those involving CMO (outsourced) manufacturing. We also make recommendations to standardize processes unique to the CGT supply chain, emphasizing the need to maintain needle-to-needle traceability from product collection to infusion. These guidelines will inform the development of more complex supply-chain models for larger-scale cell and gene therapeutics.