Georgia Tech Manufacturing Institute, Georgia Institute of Technology, Atlanta, Georgia, USA.
Georgia Tech Manufacturing Institute, Georgia Institute of Technology, Atlanta, Georgia, USA; School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, Georgia, USA.
Cytotherapy. 2019 Oct;21(10):1081-1093. doi: 10.1016/j.jcyt.2019.07.002. Epub 2019 Aug 21.
Autologous cell therapy (AuCT) is an emerging therapeutic treatment that is undergoing transformation from laboratory- to industry-scale manufacturing with recent regulatory approvals. Various challenges facing the complex AuCT manufacturing and supply chain process hinder the scale out and broader application of this highly potent treatment.
We present a multiscale logistics simulation framework, AuCT-Sim, that integrates novel supply chain system modeling algorithms, methods, and tools. AuCT-Sim includes a single facility model and a system-wide network model. Unique challenges of the AuCT industry are analyzed and addressed in AuCT-Sim. Decision-supporting tools can be developed based on this framework to explore "what-if" manufacturing and supply chain scenarios of importance to various cell therapy stakeholder groups.
Two case studies demonstrate the decision-supporting capability of AuCT-Sim where one investigates the optimal reagent base stocking level, and the other one simulates a reagent supply disruption event. These case studies serve as guidelines for designing computational experiments with AuCT-Sim to solve specific problems in AuCT manufacturing and supply chain.
This simulation framework will be useful in understanding the impact of possible manufacturing and supply chain strategies, policies, regulations, and standards informing strategies to increase patient access to AuCT.
自体细胞疗法（AuCT）是一种新兴的治疗方法，随着最近的监管批准，它正从实验室规模制造向工业规模制造转变。AuCT 制造和供应链流程面临的各种挑战阻碍了这种高效治疗方法的规模化应用。
我们提出了一个多尺度物流模拟框架 AuCT-Sim，它集成了新颖的供应链系统建模算法、方法和工具。AuCT-Sim 包括一个单一设施模型和一个系统范围的网络模型。AuCT-Sim 分析和解决了 AuCT 行业的独特挑战。可以基于该框架开发决策支持工具，以探索对各种细胞治疗利益相关者群体重要的“假设”制造和供应链场景。
两个案例研究展示了 AuCT-Sim 的决策支持能力，其中一个研究了最佳试剂基础库存水平，另一个模拟了试剂供应中断事件。这些案例研究为使用 AuCT-Sim 设计计算实验以解决 AuCT 制造和供应链中的具体问题提供了指导。
该模拟框架将有助于理解可能的制造和供应链策略、政策、法规和标准对增加患者获得 AuCT 的影响。
