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; 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.

该项目将为C-SOP开发的连续药品制造技术做出巨大的商业化工作。这种制造方法可以使产品质量，过程鲁棒性和生产力以及制造过程的整体经济绩效能够显着提高。目前，在美国FDA和大型药品制造商中，目前存在着高度的兴趣，其中许多是C-SOP成员。许多也是C-SOP成员的技术供应商也表明，人们对满足这一市场需求的兴趣非常兴趣。成功商业化所需的关键丢失要素是，目前，没有一个技术供应商拥有解决此商业机会所需的所有必要功能。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它们能够商业化完全集成的“转弯密钥”制造系统。该提案的智力优点具有三个主要组成部分。 （1）该项目将带给市场商业级集成技术，用于连续制造，该技术是基于对制造系统主要组成部分的深入理解而设计和优化的。 （2）该项目将扩大C-SOP上连续制造的现有范围，目前包括通过直接压缩或干颗粒制造的未涂层平板电脑。我们将添加功能，以实现通过直接混合，干燥颗粒和湿砂制造的涂层和未涂层​​的片剂和胶囊的连续制造。 （3）该项目将展示工程方法对药品产品和过程设计和优化的影响，从而有助于促进在目前使用经验方法和批处理过程作为其主要开发和制造范式的基本行业中采用现代方法。该项目的更广泛影响也是多方面的：（1）基于预计的销售，我们预计创造了80个直接工作，致力于连续制造系统的商业化，设计和实施，以及在该项目的第三年结束之前的两倍。 （2）该项目还将在中心站点创建七个全职技术职位。 （3）该项目将展示我们的ERC开发创新的商业级制造技术的能力，帮助将其确立为药品和过程设计领域的全球学术研究中心，为我们的ERC的长期可行性和可持续性奠定了基础。 （4）综合连续技术的商业来源的可用性将导致其快速采用和实施，并会提高产品质量，更高的生产率和较低的制造成本，从而导致患者群体的价格降低。