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

University Of Delaware, Newark DE

Investigators

Abstract

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.