Keynote Speaker

Novel bioprocess technologies abound, but few are ever adopted by the industry. The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is developing technology selection and maturation platforms to help solve this problem. Our technology selection platform is built around the factory. We started by developing a consensus of industry leaders about what the key elements of future factories need to be. We then designed a factory that would meet those requirements, even though some of the enabling technology was not available today to enable the factory to be built. Another facility was designed, using existing state-of-the-art technology, and the differences between the two facilities in cost, flexibility and other KPIs is used to quantify the benefits of those the technologies, which is a key element of the business case for any new technology. The facility designs will be published so they can serve as a standard against which technology innovations can be measured.  A second platform is our protein therapeutic test bed. We have built a lab at NIIMBL headquarters at the University of Delaware that includes at 50L perfusion bioreactor with associated continuous downstream equipment capable of producing about 100 g/day of a CHO-derived version of the NIST-mAb. The platform process will also be published so it can be used as a benchmark standard for comparing technologies, especially enabling technologies identified by the Next Generation Factory project described above. We envision technology innovators bringing their technology to the lab at the University of Delaware for collaboration, but standard feedstocks will also be generated in our test bed that can be shipped to labs around the county for more preliminary evaluations.