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

这个PFI：空气研究联盟项目专注于连续制造的制药过程建模的翻译和转移，该模型源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成本有直接影响，并对美国未参保或参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，人们遭受或死于可治愈或可治疗的疾病和疾病。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机会。目前，大多数药品都是采用批量生产技术生产的。在批处理过程中，所有的材料都被同时处理，从而产生了典型的几米大小的设备，可以处理数百公斤的材料。一次处理如此多的材料不仅有问题，而且许多制药制造工艺几十年来几乎没有变化，而且成本高昂，难以规模化。用连续制造取代药品的批量生产是一项重大的技术进步，可能会改变未来几十年的制药制造格局。在一个连续的过程中，材料不断地在系统中流动，因此典型的设备将是几十厘米大小，一次可以处理几百克材料。通过简化开发和扩大规模，并允许生产发生重大变化，药品的连续制造具有变革的潜力。这将为制药业带来更低的开发和生产成本，以及更高质量的产品和更稳健的制造工艺，从而降低制造成本，造福整个社会。将建立一个产业/学术创新生态系统，为连续制造的制药过程建模的开发和商业化提供支持。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，并将这些模型链接到一个综合系统中的现有控制模型。潜在的经济影响预计将是开发工艺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。开发连续制药工艺和实施药品连续生产的一个重要部分是对这些工艺进行建模。在这个项目中，将开发集成模型来取代当前连续制造系统的试错设计模式。集成的模型将允许进行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进行开发，然后进行商业化。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制造。最终产品将包括一个由单元操作组成的过程模型库，一个包括不同类型控制器的控制器模型库，最后是连接所有这些过程模板库的能力。

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.