Commercializing of Continuous Pharmaceutical Manufacturing Technology

该项目将为C-SOPS开发的连续制药技术提供有力的商业化努力。这种制造方法可以显著提高产品质量、工艺稳健性和生产率以及制造工艺的整体经济性能。目前，美国FDA和大型制药商（其中许多是C-SOP成员）对该技术都有很高的兴趣。许多也是C-SOPS成员的技术供应商也表示对满足这一市场需求有浓厚的兴趣。成功实现商业化所需的关键缺失因素是，目前没有一个技术供应商具备抓住这一商业机会所需的所有必要能力。因此，这项建议的主要目标是在系统集成商的领导下，组成一个技术供应商联盟，通过知识转让和技术支持，使它们能够将完全集成的“交钥匙”制造系统商业化。这一建议的知识价值有三个主要组成部分。(1)该项目将为市场带来商业级的连续制造集成技术，该技术是在深入了解制造系统主要组件的基础上设计和优化的。(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片或干法制粒生产的未包衣片剂。我们将增加能力，以实现连续生产包衣和未包衣片剂和胶囊，通过直接混合，干法制粒和湿法制粒生产。(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目前使用经验方法和批处理过程作为主要开发和制造范式的重要行业中的采用。该项目的更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，致力于连续制造系统的商业化，设计和实施，到该项目的第三年年底，间接就业机会可能会增加一倍。(2)该项目还将在中心站点创建7个全职技术职位。(3)该项目将展示我们ERC开发创新商业级制造技术的能力，帮助将其建立为制药产品和工艺设计领域首屈一指的全球学术研究中心，为我们ERC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，并将导致产品质量的提高，生产率的提高和制造成本的降低，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.