Commercializing of Continuous Pharmaceutical Manufacturing Technology

该项目将使C-SOPS开发的连续制药技术能够大力商业化。这种制造方法可以显著提高产品质量、过程稳健性和生产率，以及制造过程的整体经济性能。目前，美国食品药品监督管理局和大型制药公司对这项技术都非常感兴趣，其中许多都是C-SOPS成员。许多同样是C-SOPS成员的技术供应商也对满足这一市场需求表示了浓厚的兴趣。成功商业化所缺少的关键因素是，目前没有任何一家技术供应商具备处理这一商业机会所需的全部必要能力。因此，该提案的主要目标是组建一个由系统集成商领导的技术供应商联盟，并通过知识转移和技术支持使他们能够将完全集成的“交钥匙”制造系统商业化。这一建议的智力价值主要有三个组成部分。(1)本项目将在深入了解制造系统主要组成部分的基础上设计和优化商业级连续制造集成技术，并将其推向市场。(2)该项目将扩大C-SOPS现有的连续生产范围，目前包括通过直接压缩或干造粒生产的无包衣片剂。我们将增加能力，使通过直接混合、干造粒和湿造粒生产的包衣和非包衣片剂和胶囊能够连续生产。(3)该项目将展示工程方法对制药产品和工艺设计和优化的影响，帮助促进现代方法在一个重要行业的采用，该行业目前使用经验方法和批量工艺作为其主要的开发和制造范式。该项目的广泛影响也是多方面的：(1)根据预计的销售额，我们预计将创造80个直接就业机会，致力于商业化，设计和实施连续制造系统，到该项目第三年结束时，可能会有两倍的间接就业机会。(2)该项目还将在中心站点创造7个全职技术职位。(3)该项目将展示我们的研究中心在开发创新商业级制造技术方面的能力，帮助其成为全球首屈一指的医药产品和工艺设计学术研究中心，为我们的研究中心的长期可行性和可持续性奠定基础。(4)集成连续技术的商业来源的可用性将导致其快速采用和实施，并将导致改进的产品质量，更高的生产率和更低的制造成本，可能导致患者群体的价格降低。

This project will enable a vigorous commercialization effort for continuous pharmaceutical manufacturing technology developed by C-SOPS. This manufacturing approach can enable significant improvements in product quality, process robustness and productivity, and overall economic performance of the manufacturing process. A high level of interest exists at the present time in this technology, both by the US FDA, and by large pharmaceutical manufacturers, many of which are C-SOPS members. Many technology suppliers that are also members of C-SOPS have also indicated a keen interest in addressing this market need. The key missing element needed for successful commercialization is that, at the present time, no single technology supplier has all the necessary capabilities required to address this commercial opportunity. Thus, the main goal of this proposal is to assemble a coalition of technology suppliers, led by a systems integrator, and to enable them, by knowledge transfer and technical support, to commercialize fully integrated "turn key" manufacturing systems. The Intellectual Merit of this proposal has three main components. (1) This project will bring to the market place commercial-grade integrated technology for continuous manufacturing that is designed and optimized based on an in-depth understanding of the main components of the manufacturing system. (2) This project will expand the existing scope of continuous manufacturing at C-SOPS, which currently comprises uncoated tablets manufactured either via direct compression or dry granulation. We will add capabilities to enable the continuous manufacturing of both coated and uncoated tablets and capsules manufactured by direct blending, dry granulation, and wet granulation. (3) This project will demonstrate the impact of engineering methods for pharmaceutical product and process design and optimization, helping promote adoption of modern methodologies across an essential industry that at the present time uses empirical methods and batch processes as its main development and manufacturing paradigm. The Broader Impact of this project is also manifold: (1) Based on projected sales, we anticipate creation of 80 direct jobs, devoted to the commercialization, design, and implementation of continuous manufacturing systems, and perhaps twice as many indirect jobs by the end of the third year of this project. (2) The project will also create seven full time technical positions at center sites. (3) This project will demonstrate the capabilities of our ERC to develop innovative commercial-grade manufacturing technology, helping establish it as the premier worldwide center of academic research in pharmaceutical product and process design, setting the foundation for the long term viability and sustainability of our ERC. (4) Availability of commercial sources of integrated continuous technology will lead to its rapid adoption and implementation, and will lead to improved product quality, higher productivity rates, and lower cost of manufacturing, likely resulting in price reductions for the patient population.