Phase II IUCRC at The Pennsylvania State University: Center for Membrane Science, Engineering and Technology (MAST)

该提案的总体目标是在宾夕法尼亚州立大学的膜科学、工程和技术中心（MAST）开发一个新的研究中心，重点关注生物制药行业中的膜应用，并使用宾夕法尼亚州立大学最先进的电子显微镜和断层扫描设备开发膜表征的新方法。与竞争技术相比，基于膜的分离提供了许多独特的优势，包括：较低的能量需求，相对容易放大，并且没有相变或化学添加剂。在MAST中心建立宾夕法尼亚州立大学的网站将补充和扩大现有的研究组合在膜科学和技术。宾夕法尼亚州立大学的拟议研究是专门为解决生物加工中的竞争前研究挑战而设计的，包括开发用于连续生物加工的膜技术。此外，宾州州立大学的校园将为学生培训提供理想的环境，包括妇女和来自代表性不足的少数群体的学生。宾夕法尼亚州立大学的增加将显着扩大和加强MAST中心，包括令人兴奋的新的互动与领先的生物制药公司，提供一个更强大的环境，为学生的培训，教育，和研究膜科学和技术。这NSF IUCRC建议旨在建立一个第四个网站在现有的中心膜科学，工程和技术（MAST）在宾夕法尼亚州立大学，重点是膜在生物加工中的应用，包括膜表征的新方法。许多最近的发展正在刺激对用于生物处理的膜的进一步兴趣。低成本国际制造商的增长和生物仿制药的出现带来了巨大的经济压力。从当前的批处理过程过渡到连续操作也有很大的兴趣，其目标是提高产品质量，提高制造灵活性和提高整体生产率。 具体项目将解决膜技术在生物加工中应用的关键挑战，包括病毒去除过滤过程中的污染和病毒捕获问题，用于产品收获和细胞再循环的切向流过滤与灌注生物反应器的整合，以及用于连续产品浓缩和配制的单程切向流过滤/渗滤的使用。 这些项目将充分利用宾夕法尼亚州立大学在生物加工方面的专业知识，沿着最先进的膜表征设施，提供重要的基本见解，解决生物加工中膜技术的关键竞争前研究挑战。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The overall objective of this proposal is to develop a new Site in the Center for Membrane Science, Engineering and Technology (MAST) at The Pennsylvania State University with a specific focus on membrane applications in the biopharmaceutical industry and the development of novel methods for membrane characterization using state-of-the-art electron microscopy and tomography facilities at Penn State. Membrane-based separations offer a number of unique advantages compared to competing technologies including: lower energy requirements, relative ease of scale-up, and no phase changes or chemical additives. The establishment of a Penn State Site in the MAST Center will both complement and expand upon the existing research portfolio in membrane science and technology. The proposed research at Penn State is specifically designed to address pre-competitive research challenges in bioprocessing, including the development of membrane technology for use in continuous bioprocessing. In addition, the Penn State site will provide an ideal environment for student training, including both women and students from under-represented minority groups. The addition of the Penn State site will significantly expand and strengthen the MAST Center, including exciting new interactions with leading biopharmaceutical companies, providing an even stronger environment for student training, education, and research in membrane science and technology.This NSF IUCRC proposal aims to establish a 4th site within the existing Center for Membrane Science, Engineering and Technology (MAST) at The Pennsylvania State University with a focus on applications of membranes in bioprocessing, including new methods for membrane characterization. A number of recent developments are spurring further interest in membranes for bioprocessing. There are significant economic pressures associated with the growth in low-cost international manufacturers and the advent of biosimilars. There is also significant interest in transitioning from current batch processes to continuous operations, with the goal of enhancing product quality, improving manufacturing flexibility, and increasing overall productivity. Specific projects will address critical challenges in the application of membrane technology in bioprocessing, including issues of fouling and virus capture during virus removal filtration, integration of tangential flow filtration for product harvest and cell recycle with perfusion bioreactors, and the use of single pass tangential flow filtration / diafiltration for continuous product concentration and formulation. These projects will fully exploit the expertise at Penn State in bioprocessing along with state-of-the-art facilities for membrane characterization, providing significant fundamental insights that address critical pre-competitive research challenges in membrane technology in bioprocessing.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.