PFI:AIR-RA: Commercializing Pharmaceutical Process Modeling for Continuous Manufacturing

PFI：AIR-RA：连续制造的制药工艺建模商业化

• 批准号: 1537197
• 负责人: Benjamin Glasser
• 金额: $ 80万
• 依托单位: Rutgers University New Brunswick
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-10-01 至 2019-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1537197&HistoricalAwards=false
• 关键词: PFI; AIR; RA; Commercializing; Pharmaceutical

This PFI: AIR Research Alliance project focuses on the translation and transfer of pharmaceutical process modeling for continuous manufacturing, derived from the Engineering Research Center for Structured Organic Particulate Systems (ERC-SOPS). The high cost of pharmaceuticals has a direct effect on healthcare costs and is a financial burden on uninsured or underinsured populations in the US. In the developing world, people suffer or die from curable or treatable diseases and illnesses due to a lack of affordable pharmaceuticals. Reducing manufacturing costs through innovations and technology transfer represents an opportunity to significantly bring down the cost of pharmaceuticals. At the present most pharmaceuticals are produced using batch manufacturing technology. In a batch process all of the material is processed at the same time leading to typical equipment that is meters in size that would process hundreds of kilograms of material. Not only is it problematic to process so much material at once, many pharmaceutical manufacturing processes have changed little in decades, and are expensive and difficult to scale. Replacing batch manufacturing of pharmaceuticals with continuous manufacturing is a major technology advance that can change the landscape of pharmaceutical manufacturing in the next decades. In a continuous process, material flows continuously through the system so typical equipment would be tens of centimeters in size and would process a few hundred grams of material at a time. Continuous manufacturing of pharmaceuticals has the potential to be transformative by simplifying development and scale up, and allowing major changes in production. This will result in lower development and production costs for the pharmaceutical industry, and higher quality products and more robust manufacturing processes that will reduce manufacturing costs and benefit society as a whole. An industry/academic innovation ecosystem will be established for the development and commercialization of pharmaceutical process modeling for continuous manufacturing. The innovation ecosystem that will be created includes Janssen Supply Group, Patheon and Control Associates/QbD Process Technologies. A framework for connecting the process models will be established, and these will be linked to available control models in an integrated system. The potential economic impact is expected to be development of process models and commercial modeling software and creation of new jobs in the next 3-5 years. Students and post-doctoral fellows will gain entrepreneurial and technology translation experience through training materials, seminars and meetings with entrepreneurs. An essential part of the development of continuous pharmaceutical processes and the implementation of continuous manufacturing of pharmaceuticals is modeling of these processes. In this project, integrated models will be developed to replace the current mode of trial-and-error design of a continuous manufacturing system. The integrated models will allow for model guided experiments and state-of-the-art process design and will be developed as part of the ecosystem and then commercialized. In this ecosystem, a repository of unit operations will be developed that can be used to model continuous manufacturing of pharmaceuticals. The end product will include a process model library consisting of unit operations, a controller model library that includes different kinds of controllers, and finally the capability of connecting all of these libraries of process templates.

该PFI：AIR研究联盟项目的重点是连续制造的制药过程建模的翻译和转移，来自结构化有机颗粒系统工程研究中心（ERC-SOPS）。药品的高成本对医疗保健成本有直接影响，并且对美国未投保或投保不足的人群造成经济负担。在发展中国家，由于缺乏负担得起的药品，人们患上或死于可治愈或可治疗的疾病。通过创新和技术转让降低制造成本是大幅降低药品成本的一个机会。目前，大多数药品都是使用批量生产技术生产的。在批量过程中，所有的材料都在同一时间处理，导致典型的设备尺寸为米，可以处理数百公斤的材料。不仅一次处理这么多材料是有问题的，而且许多制药工艺几十年来几乎没有变化，而且价格昂贵，难以规模化。用连续生产取代药品的批量生产是一项重大的技术进步，可以在未来几十年内改变药品生产的格局。在连续工艺中，材料连续流过系统，因此典型的设备尺寸为数十厘米，一次可处理数百克材料。药品的连续生产有可能通过简化开发和扩大规模以及允许生产的重大变化而实现变革。这将降低制药行业的开发和生产成本，并提高产品质量和更强大的制造工艺，从而降低制造成本，造福整个社会。 将建立一个工业/学术创新生态系统，用于开发和商业化用于连续制造的制药过程建模。 将创建的创新生态系统包括Janssen Supply Group、Patheon和Control Associates/QbD Process Technologies。将建立一个连接过程模型的框架，这些模型将与集成系统中的现有控制模型相联系。潜在的经济影响预计将是开发过程模型和商业建模软件，并在未来3-5年内创造新的就业机会。 学生和博士后研究员将通过培训材料，研讨会和与企业家的会议获得创业和技术翻译经验。连续制药工艺的开发和药品连续生产的实施的一个重要组成部分是这些过程的建模。 在这个项目中，将开发综合模型，以取代目前的连续制造系统的试错设计模式。集成模型将允许模型指导实验和最先进的工艺设计，并将作为生态系统的一部分开发，然后商业化。在这个生态系统中，将开发一个单元操作库，可用于模拟药品的连续生产。 最终产品将包括由单元操作组成的过程模型库、包括不同类型控制器的控制器模型库，以及最终连接所有这些过程模板库的能力。