Srai Jagjit Singh, Badman Clive, Krumme Markus, Futran Mauricio, Johnston Craig
Department of Engineering, Institute for Manufacturing, University of Cambridge, Cambridge, United Kingdom.
Pre-Competitive Activities, GlaxoSmithKline, Stevenage, United Kingdom.
J Pharm Sci. 2015 Mar;104(3):840-849. doi: 10.1002/jps.24343. Epub 2016 Jan 8.
This paper examines the opportunities and challenges facing the pharmaceutical industry in moving to a primarily "continuous processing"-based supply chain. The current predominantly "large batch" and centralized manufacturing system designed for the "blockbuster" drug has driven a slow-paced, inventory heavy operating model that is increasingly regarded as inflexible and unsustainable. Indeed, new markets and the rapidly evolving technology landscape will drive more product variety, shorter product life-cycles, and smaller drug volumes, which will exacerbate an already unsustainable economic model. Future supply chains will be required to enhance affordability and availability for patients and healthcare providers alike despite the increased product complexity. In this more challenging supply scenario, we examine the potential for a more pull driven, near real-time demand-based supply chain, utilizing continuous processing where appropriate as a key element of a more "flow-through" operating model. In this discussion paper on future supply chain models underpinned by developments in the continuous manufacture of pharmaceuticals, we have set out; The paper recognizes that although current batch operational performance in pharma is far from optimal and not necessarily an appropriate end-state benchmark for batch technology, the adoption of continuous supply chain operating models underpinned by continuous production processing, as full or hybrid solutions in selected product supply chains, can support industry transformations to deliver right-first-time quality at substantially lower inventory profiles. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association.
本文探讨了制药行业在转向主要基于“连续加工”的供应链过程中所面临的机遇与挑战。当前主要为“重磅炸弹”药物设计的“大批量”和集中式生产系统,催生了一种节奏缓慢、库存量大的运营模式,这种模式日益被视为缺乏灵活性且不可持续。事实上,新市场和迅速演变的技术格局将带来更多样的产品、更短的产品生命周期以及更小的药品产量,这将使本就不可持续的经济模式更加恶化。尽管产品复杂性增加,但未来的供应链仍需提高患者和医疗服务提供者的可承受性和可得性。在这种更具挑战性的供应情形下,我们研究了采用更具拉动性、基于近乎实时需求的供应链的潜力,在适当情况下将连续加工作为更“直通式”运营模式的关键要素。在这篇基于药品连续制造发展的关于未来供应链模式的讨论论文中,我们阐述了;本文认识到,尽管制药行业目前的批次运营绩效远非最佳,且不一定是批次技术合适的最终状态基准,但在选定产品供应链中采用以连续生产加工为支撑的连续供应链运营模式,作为完整或混合解决方案,能够支持行业转型,以大幅降低库存水平的同时首次实现正确的质量。© 2015作者。《药物科学杂志》由威利期刊公司和美国药剂师协会出版。