Manufacturing automation within the supply chain to ensure patient safety

细胞治疗行业为改变医疗保健提供了巨大的机会。然而，目前的制成品数量是有限的，制造工艺需要进行重大改造，才能应对潜在的需求。该提案旨在创建一个演示器，通过自动化存储和从多个大容量低温存储设备中检索样品瓶来实现灵活制造。采用这种技术/解决方案需要细胞治疗部门开发一个集成的供应链，以增加制成品的数量。目前的项目将首先稳定并随后发展强大的制药供应链。为了实现这一目标，该项目将在Fisher Bioservices开发和实施新的快速原型和制造能力。这种以设计为导向的方法将降低开发过程早期阶段的风险，从而显著提高损耗率和投资回报率。该公司将被公认为引领细胞治疗产品开发的转型。这些好处不仅限于公司、客户和供应链合作伙伴，而且将在整个价值链中实现，包括患者和更广泛的社会。克兰菲尔德的主要职责是调查改善方案，以解决已发现的瓶颈。这将着眼于开发工具和流程，以改善制造和供应链。根据本工作方案的主要目标，确定了以下目标：1.回顾合适的模拟方法（线性优化，离散事件，基于代理和系统动力学）。这将包括最近在基因治疗，航空航天和国防制造（这是相对小批量，高度先进的技术制造）的研究。设计和开发计算机模拟模型，以优化制造（和供应链）工作流程。这将涉及到使用商业现成的软件包和定制的工具，以改善自动化决策。制定创新路线图，将模拟模型的结果嵌入到WP 3（模块化集成自动化低温存储架构的开发）和WP 4（下一代工厂）中。用真实的系统验证仿真建模的结果和发现。这可以通过多个专家工作室完成，并与历史数据进行比较，克兰菲尔德大学将参与整个WP。此外，WP 2将有助于其他WP如下：1.根据WP 1（当前医疗系统评估）中定义的工作范围，克兰菲尔德大学将与细胞治疗弹射器和其他机构密切合作，共同进行审查并从WP 12中获得知识。WP 3提供开发模拟模型所需的相关数据（例如自动化类型、自动化程度、自动化成本）3. WP 4提供设计拟议生产系统所需的相关数据4。WP 3的具体输出包括各种决策工具集，以确定自动化可以应用于何处以及如何应用，通过自动化可以节省多少时间和成本，未来的供应链将是什么样子。工业验证的案例报告，展示使用模拟建模的自动化策略的好处. WP 4的具体输出包括FBS制造供应链的优化流程配置6。项目合作伙伴需要不时验证所开发的模型并提供反馈。验证分两个阶段进行：a.对所开发的模型进行检查，以确认符合真实的系统（由FBS完成）B。检查模拟结果是否与初始评估一致并符合目标（由FBS和细胞治疗弹射器完成）

The cell therapy industry is offering huge opportunities to transform the way healthcare is delivered. However, the currentamount of manufactured goods is limited and the manufacturing processes require drastic transformation to be able torespond to the potential demand. This proposal will aim to create a demonstrator that allows flexible manufacturing byautomating the storage and retrieval of sample vials from multiple large capacity Cryogenic storage devices. Adopting thistechnology / solution requires the cell therapy sector to develop an integrated supply chain to enhance the number ofmanufactured goods. The current project will first stabilise and subsequently grow robust pharmaceutical supply chains.In order to achieve this, the project will develop and implement novel rapid prototyping and manufacturing capability atFisher Bioservices. This design-led approach will reduce risk in the early stages of the development process, therebydramatically improving attrition rates and return on investment. The company will be recognised as leading thetransformation of developing cell therapy goods. The benefits are not limited to the company, its clients and supply chainpartners but will be realised across the whole value chain, including patients and wider society.Cranfield's main role focuses on investigate the improvement options to address the bottlenecks identified. This will lookinto developing tools and processes improving the manufacturing and supply chain. In line with the main aim of this WP,the following objectives are defined:1. Review suitable simulation approaches (Linear Optimisation, Discrete Event, Agent Based, and System Dynamics). Thiswill incorporate recent research in Gene Therapy, Aerospace and DefenceManufacturing (which are relatively low-volume, highly advanced technological manufacturing)2. Design and develop computerised simulation models to optimise the manufacturing (and supply chain) workflows. Thiswill involve using commercial off the shelf software packages and bespoketools developed for improving decisions in automation.3. Develop an innovation roadmap to embed the findings from the simulation models which will feed into WP3(DEVELOPMENT OF A MODULAR INTEGRATED AUTOMATED CRYOGENIC STORAGEARCHITECTURE) and WP 4 (NEXT GENERATION FACILITY)4. Validate the results and findings from simulation modelling with the real system. This can be done by multi-expertworkshops and comparisons with historical dataCranfield University will be involved across the WPs. Furthermore, WP 2 will be contributing to other WPs as coveredbelow:1. Based on the scope of work defined in WP1 (ASSESSMENT OF CURRENT MANUAL SYSTEMS), Cranfield Universitywill work closely with the Cell Therapy Catapult and others to collaborativelyconduct the review and gain knowledge from WP12. WP3 to provide relevant data required to develop simulation models (e.g. type of automation, degree of automation,cost of automation)3. WP4 to provide relevant data required to design the proposed production system4. Specific outputs to WP3 include various Decision making toolsets to identify where and how automation can be applied,what time and cost savings can be achieved through automation, what is the future supply chain going to look like. Casereports for industrial validations demonstrating the benefits of automation strategy using simulation modelling.5. Specific outputs to WP4 include optimised process configurations for FBS manufacturing supply chains6. From time to time the project partners need to validate the model developed and provide feedback. Validation to happen in 2 stages:a. To check of the model developed confirms to the real system (to be done by FBS)b. To check if the results from simulations are consistent with the initial assessment and meets the targets (to be done byFBS and Cell Therapy Catapult)