From Concept to Market – Unique approaches in Biomanufacturing
18th September 2019 | 9:30am CEST/ 15:00 China Time | Jincai Li, Vice President of WuXi Biologics and Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific |BOOK FREE SEAT
With the rapid growth of the biotherapeutics industry, the need and challenge for high quality, cost efficient production has been increasing as well. At the same time, the number of approved biologics products are also steadily increasing, and more and more products are being developed by small to mid-size biotech companies, with product market size that vary greatly and therefore leading to varying production scale needs. The presentation will talk about the paradigm shifts in today’s facility design and operations, with multi-purpose facility and smaller, modular facility being favored by many companies. In addition, rapid adoption of disposable technology has enabled faster and lower cost facility design & start-up. With the modular, disposable technologies, the unique “scale-out” approach has the advantage of providing highest flexibility to customers while simultaneously lowering tech transfer and scale-up risks. The presentation will also cover the somewhat unique challenge of transitioning from clinical manufacturing to commercial manufacturing, and maintaining both clinical and commercial manufacturing in the same facility.
Presented by Dr. Jincai Li, Vice President of WuXi Biologics
Dr. Jincai (Jimmy) Li is currently Vice President of WuXi Biologics. Dr. Li has over 17 years’ experience in Biologics process development, scale-up and cGMP manufacturing. His group contributed to over 40 IND submissions, both in and outside of China, as well as BLA submission works. Dr. Li joined WuXi Biologics in 2011, helped built and led the Cell Culture Process Development & pilot plant production group, and then managed the cGMP Drug Substance manufacturing facility. Before joining WuXi Biologics, Dr. Li was a cell culture process development Group Leader at Genentech Inc. Before that, Dr. Li also worked at Tanox, Inc, where he led the manufacturing sciences group supporting PhIII production of a mAb product, and at Diversa Corporation (now BASF), in charge of process development for multiple recombinant enzyme projects. Dr. Li holds B.S. degree from Tsinghua University, and Ph.D. degree from University of Maryland Baltimore County, majoring in Chemical and Biochemical Engineering.
Followed by Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific
Kevin Mullen is a Sr. Product Manger at Thermo Fisher Scientific, based in Logan Utah. For the past 2.5 years, Kevin has been managing the Single-Use Bioreactors and Single-Use Fermentors portfolio. In his role, Kevin is working closely with the development team to enhance and better characterize the performance attributes of single-use hardware systems. Prior to joining Thermo Fisher, he spent 13 years as an engineer and product manager in the medical device industry. Kevin holds an M.S. degree and an MBA from Utah State University majoring in Biological Engineering and business respectively.
Sponsored by Thermo Fisher Scientific
Thermo Fisher Scientific supports developers and manufacturers of biological-based therapeutics and vaccines with a world-class product portfolio that spans the bioprocessing workflow from discovery through large-scale commercial production. Starting with production-grade raw materials and supply chain logistics, we provide solutions and services across the manufacturing value stream and through QC release of finished goods, including upstream cell culture, downstream purification, analytical and QC testing, end-to-end single-use technologies, and comprehensive measurement and control solutions.