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

生物制药行业是美国和世界范围内技术要求最高、影响最大的行业之一，是科学创新和经济繁荣的驱动力。以蛋白质为活性成分的新药是增长最快、最有前景的新药候选之一。然而，在这种药用蛋白质的开发和制造过程中，存在着一些长期存在的、全行业范围的挑战。拟议中的位于特拉华大学(UD)的I/UCRC网站将为现有的药物开发中心(CPD)带来世界级的专业知识，这些领域是开发药用蛋白质(所谓的生物制药)创新的核心技术领域。例如：更高效的纯化工艺，更好的产品稳定性和降低患者副作用或不想要的免疫原性反应的风险，以及改进对制造工艺的控制。拟议中的扩大后的CPD将是迄今为止影响最深远的产学研联盟，专注于医药产品开发，而不是更传统的专注于上游？研究和药物发现活动。它将涉及的项目领域有可能极大地提高药物开发科学和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。基于新的治疗蛋白(UD网站的唯一重点)和更广泛的创新药物产品(CPD整体的重点)的开发和测试，这可以在创造国内就业机会、缩短上市时间、患者成本和降低投资者风险方面使美国普遍受益。生物制药行业的主要技术领域集中在CPD的UD场地，包括：(I)商业和中试规模的生物反应器，以生产用作药物的重组蛋白；(Ii)广泛的纯化，以生产基本上纯的水溶液中的治疗性蛋白；(Iii)纯化蛋白的配方，以确保多年的稳定性、坚固的制造和有效的给药；(Iv)分析技术和仪器，以支持在(I)至(Iii)阶段中每个阶段的极其严格的规格。为CPD建议的UD地点的教员在(I)至(Iv)领域是世界公认的领导者，并将为当前的CPD提供新的优势，补充固态药物稳定性和输送以及工业酶和相关生物技术产品开发的现有专业知识。

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.