I/UCRC Phase I (Site): Center for Pharmaceutical Development U. of Delaware Site

I/UCRC 第一阶段（现场）：特拉华大学药物开发中心现场

• 批准号: 1540003
• 负责人: Christopher Roberts
• 金额: $ 32.5万
• 依托单位: University of Delaware
• 依托单位国家: 美国
• 项目类别: Continuing Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-10-01 至 2020-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1540003&HistoricalAwards=false
• 关键词: UCRC; Phase; Site; Center; Pharmaceutical

The biopharmaceutical industry represents one of the most technically demanding, high impact industries in the United States and worldwide, and is a driver of scientific innovation and economic prosperity. One of the fastest growing, and most promising type of new drug candidates, are those based on proteins as the active ingredient. However, there are a number of long-standing, industry-wide challenges that occur during the development and manufacturing of such ?pharmaceutical proteins?. The proposed I/UCRC Site at the University of Delaware (UD) will bring world-class expertise to the existing Center for Pharmaceutical Development (CPD), in technical areas that are central to innovation for the development of pharmaceutical proteins (so-called biopharmaceuticals). Examples include: more efficient purification processes, better product stability and reduced risk of side effects or unwanted immunogenic responses in patients, and improved control of manufacturing processes. The proposed, expanded CPD will be the most far-reaching industry-university consortium to date that is focused on pharmaceutical product development, rather than the more traditional focus on ?upstream? research and drug-discovery activities. The project areas it will address have the potential to greatly improve the efficiency and economics of drug development science and engineering, as well as the fundamental understanding and education of engineers and scientists in the industry. This can benefit the U.S. broadly in terms of domestic job creation, as well as improved time to market, cost to patients, and reduced risk for investors, based on the development and testing of new therapeutic proteins (sole focus of the UD Site) and innovator pharmaceutical products more generally (focus of CPD overall). The major technical areas for the biopharmaceutical industry that are the focus on the UD site for the CPD include: (i) commercial and pilot-scale bioreactors to produce recombinant protein for use as a drug; (ii) extensive purification to produce essentially pure therapeutic protein in aqueous solution; (iii) formulation of the purified protein to assure multi-year stability, robust manufacturing, and effective delivery to patients; (iv) analytical technologies and instrumentation to support extremely tight specifications at each of stages (i) to (iii). The faculty in the proposed UD Site for the CPD are world-recognized leaders in areas (i) to (iv), and will provide new strengths to the current CPD that complement the existing expertise in solid-state pharmaceutical stability and delivery, and development of industrial enzymes and related biotechnology products.

生物制药行业是美国和全球技术要求最高、影响最大的行业之一，是科学创新和经济繁荣的驱动力。 增长最快、最有前途的新候选药物之一是以蛋白质为活性成分的药物。 然而，在此类“药用蛋白质”的开发和制造过程中，存在许多长期存在的全行业挑战。 拟议的 I/UCRC 站点位于特拉华大学 (UD)，将为现有的药物开发中心 (CPD) 带来世界一流的专业知识，涉及药物蛋白（所谓的生物制药）开发创新的核心技术领域。 ）。 例子包括：更有效的纯化工艺、更好的产品稳定性、降低副作用或患者不需要的免疫原性反应的风险，以及改进生产工艺的控制。 拟议的、扩大的 CPD 将成为迄今为止影响最深远的工业大学联盟，专注于药品开发，而不是更传统的“上游”。研究和药物发现活动。 它将涉及的项目领域有可能大大提高药物开发科学与工程的效率和经济性，以及该行业工程师和科学家的基本理解和教育。 基于新治疗蛋白的开发和测试（UD 网站的唯一焦点）和更广泛的创新医药产品（整体 CPD 的重点）。 生物制药行业 CPD 中心重点关注的主要技术领域包括： (i) 生产用作药物的重组蛋白的商业和中试规模生物反应器； (ii) 广泛纯化以在水溶液中产生基本上纯的治疗性蛋白质； (iii) 纯化蛋白质的配方，以确保多年稳定性、稳健的生产以及有效地输送给患者； (iv) 分析技术和仪器，以支持 (i) 至 (iii) 每个阶段的极其严格的规格。拟议的 CPD UD 中心的教师是 (i) 至 (iv) 领域世界公认的领导者，将为当前的 CPD 提供新的优势，补充固态药物稳定性和输送以及开发方面的现有专业知识工业酶和相关生物技术产品。