Abstract Estimations of the facility footprint and fixed capital investment (FCI) of cell therapy (CT) facilities need to consider the unique features of the single-use technologies (SUTs) selected for CT manufacture (e.g. cleanroom containment requirement, capacity, automation) and the product nature that impacts scale-out versus scale-up approaches. A novel detailed factorial methodology is proposed for estimating FCI and footprint for bespoke stick-built cell therapy facilities that accounts for technology-specific factors for key cell culture technologies as well as the implications of SUTs, open versus closed operations and the commercialisation scenario selected. This was used to derive benchmark values for short-cut cost and area factors for typical cell therapy facilities according to the technologies selected. The results provide project-specific ratios for equipment purchase costs to facility footprint (area factor) and for FCI to total equipment purchase costs (cost factor or “Lang” factor). Area factors ($/m2) were 675-6,815 and the cost factors were 2.3–8.5 for a greenfield project in a medium-developed country. The case study shows that for the same output, facility footprints and FCI values are on average 6 times higher for autologous processes than allogeneic processes. This is attributed to economies of scale achieved with scale-up for allogeneic cell therapy manufacture. This study can be used to predict the commercial FCI and facility footprint during early stages of process development.

中文翻译：

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估算细胞治疗设施的资本投资和设施足迹

摘要 细胞治疗 (CT) 设施的设施占地面积和固定资本投资 (FCI) 的估计需要考虑为 CT 制造选择的一次性技术 (SUT) 的独特特征（例如洁净室密封要求、容量、自动化）和影响横向扩展与纵向扩展方法的产品性质。提出了一种新颖的详细因子方法，用于估计定制棒状细胞治疗设施的 FCI 和足迹，该方法考虑了关键细胞培养技术的技术特定因素以及 SUT、开放与封闭操作和所选商业化场景的影响。这用于根据所选技术得出典型细胞治疗设施的捷径成本和面积因素的基准值。结果提供了设备采购成本与设施占地面积（面积系数）和 FCI 与总设备采购成本（成本系数或“Lang”系数）的特定项目比率。对于中等发达国家的绿地项目，面积系数（$/m2）为 675-6,815，成本系数为 2.3-8.5。案例研究表明，对于相同的输出，自体过程的设施足迹和 FCI 值平均比异体过程高 6 倍。这归因于同种异体细胞疗法生产的扩大规模所实现的规模经济。该研究可用于在工艺开发的早期阶段预测商业 FCI 和设施足迹。对于中等发达国家的绿地项目，面积系数（$/m2）为 675-6,815，成本系数为 2.3-8.5。案例研究表明，对于相同的输出，自体过程的设施足迹和 FCI 值平均比异体过程高 6 倍。这归因于同种异体细胞疗法生产的扩大规模所实现的规模经济。该研究可用于在工艺开发的早期阶段预测商业 FCI 和设施足迹。对于中等发达国家的绿地项目，面积系数（$/m2）为 675-6,815，成本系数为 2.3-8.5。案例研究表明，对于相同的输出，自体过程的设施足迹和 FCI 值平均比异体过程高 6 倍。这归因于同种异体细胞疗法生产的扩大规模所实现的规模经济。该研究可用于在工艺开发的早期阶段预测商业 FCI 和设施足迹。这归因于同种异体细胞疗法生产的扩大规模所实现的规模经济。该研究可用于在工艺开发的早期阶段预测商业 FCI 和设施足迹。这归因于同种异体细胞疗法生产的扩大规模所实现的规模经济。该研究可用于在工艺开发的早期阶段预测商业 FCI 和设施足迹。