Commercializing of Continuous Pharmaceutical Manufacturing Technology

连续药物制造技术的商业化

• 批准号: 0951845
• 负责人: Marianthi Ierapetritou
• 金额: $ 180万
• 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: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2013-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0951845&HistoricalAwards=false
• 关键词: Commercializing; Continuous; Pharmaceutical; Manufacturing; Technology

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.

该项目将使 C-SOPS 开发的连续药品制造技术能够大力商业化。这种制造方法可以显着提高产品质量、工艺稳健性和生产率以及制造过程的整体经济绩效。目前，美国 FDA 和大型制药制造商（其中许多是 C-SOPS 成员）都对这项技术表现出浓厚的兴趣。许多也是 C-SOPS 成员的技术供应商也对满足这一市场需求表现出了浓厚的兴趣。成功商业化所需的关键缺失要素是，目前没有任何一家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，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，并通过知识转让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。该提案的智力价值包括三个主要组成部分。 (1) 该项目将把基于对制造系统主要组成部分的深入了解而设计和优化的商业级连续制造集成技术推向市场。 (2) 该项目将扩大 C-SOPS 连续生产的现有范围，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，以连续生产通过直接混合、干法制粒和湿法制粒生产的包衣和未包衣片剂和胶囊。 (3) 该项目将展示工程方法对药品和工艺设计及优化的影响，有助于促进现代方法论在目前使用经验方法和批量工艺作为其主要开发和制造范例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 个直接就业岗位，致力于连续制造系统的商业化、设计和实施，到最后可能会创造两倍的间接就业岗位该项目的第三年。 (2) 该项目还将在中心站点设立 7 个全职技术职位。 (3) 该项目将展示我们的 ERC 开发创新商业级制造技术的能力，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，为长期生存和可持续发展奠定基础。我们的 ERC。 (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，从而可能导致患者群体的价格下降。