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An Integrated Approach to Viral Vector Manufacturing and Supply Chain Network Development

病毒载体制造和供应链网络开发的综合方法

基本信息

批准号：
2615428
负责人：
金额：
--
依托单位：
Imperial College London
依托单位国家：
英国
项目类别：
Studentship
财政年份：
2020
资助国家：
英国
起止时间：
2020 至无数据
项目状态：
未结题

来源：
https://gtr.ukri.org/projects?ref=studentship-2615428
关键词：
Integrated Approach Viral Vector Manufacturing

项目摘要

Advanced Therapy Medicinal Products (ATMPs) form a novel class of biologic therapeutics whichpave the way to prevention and treatment of life-threatening diseases. The versatility ofgenetically-engineered drug delivery vehicles is also seen in preventive healthcare, with recentapprovals of vector-based vaccine platforms. Viral vectors are currently at the forefront of bothnext-generation vaccines and therapeutics; the unprecedented demand for viral vectors forcesmanufacturers to simultaneously tackle engineering product and process-related challenges, whilescaling up their production. This is highlighting the need for sophisticated decision-making tools,which enable effective manufacturing and distribution planning throughout product lifetimes.Process systems engineering (PSE) has traditionally assisted the pharmaceutical, and moregenerally, process industries in the development of such tools. Despite the absence of worksaddressing the novel viral vector industry, a review of literature to date reveals classes oftransferable PSE tools for planning of single- and multi-site manufacturing and distribution networks;these often address complexities of flexible multi-product and multi-purpose manufacture.Computational challenges emerge alongside the problem of planning under uncertainty, which isconsidered in frameworks for capacity planning and portfolio management for the pharmaceuticalindustry. Limitations in well-established approaches emerge and the opportunity brought byapplication-driven tools for the viral vector industry to operations research is highlighted.A series of research aims and objectives is proposed, followed by an overview of the progressto date in light of said objectives. A preliminary mixed-integer linear programming (MILP) modelfor the design and optimisation of UK viral vector supply chains is presented and results illustratethe capabilities and areas of improvement of the developed snapshot model. The framework inturn relies on techno-economic analyses obtained from computer-aided modelling of well-establishedviral vector manufacturing protocols. A local sensitivity analysis highlights a need to systematicallyaccount for uncertainty of the assumed inputs when characterising model outputs.

先进的治疗药物产品（ATMP）形成了一类新的生物治疗剂，为预防和治疗危及生命的疾病铺平了道路。基因工程药物输送载体的多功能性也见于预防性医疗保健，最近批准了基于载体的疫苗平台。病毒载体目前处于下一代疫苗和治疗剂的最前沿;对病毒载体的前所未有的需求迫使制造商在扩大生产的同时，同时应对工程产品和工艺相关的挑战。这突出了对复杂的决策工具的需求，这些工具可以在整个产品生命周期内实现有效的制造和分销规划。过程系统工程（PSE）传统上帮助制药行业，更广泛地说，过程工业开发了这些工具。尽管缺乏针对新型病毒载体产业的工作，但迄今为止的文献综述揭示了用于规划单站点和多站点制造和分销网络的可转移PSE工具的类别;这些通常解决灵活的多产品和多用途制造的复杂性。计算挑战与不确定性下的规划问题一起出现，这在制药行业的能力规划和组合管理框架中得到了考虑。针对病毒载体产业的应用驱动工具给运筹学带来的机遇，提出了病毒载体产业运筹学的研究目标，并根据这些目标对病毒载体产业运筹学的研究进展进行了综述。一个初步的混合整数线性规划（MILP）模型的设计和优化的英国病毒载体供应链和结果illustratethe能力和改进的快照模型的领域。该框架反过来又依赖于从计算机辅助建模的完善的病毒载体生产协议获得的技术经济分析。局部敏感性分析强调了在描述模型输出特性时，需要系统地考虑假设输入的不确定性。