03rd June 2020 | 10.00 am EST | Dan Hill, Manufacturing Scientist at Biogen and Maryann Cuellar, Life Science Product Manager at Kaiser Optical Systems, Inc. |WATCH FOR FREE
The use of in-line Raman spectroscopy as an in-line process analytical technology (PAT), in the biotechnology industry, has matured over the past decade from a technology with promise to a standard tool for real-time, continuous monitoring of cell culture processes. There is an ever-growing body of work demonstrating successful application from metabolite and product quality monitoring to process control in both process development and GMP manufacturing environments. This is due, in part, to advances in technology robustness, user- and integration-interfaces, improved sensitivity, and fluorescence rejection. Organizations are now faced with the difficult task of best leveraging these tools and extracting the most value from them. Thus, defining and executing Raman program strategy is critical to the technology’s long-term success and sustainability.
This presentation will describe Biogen’s past efforts and strategic direction as it relates to in-line Raman spectroscopy for cell culture operations and how we intend to leverage its capability beyond metabolite monitoring and glucose feedback control to become an essential element of our Advanced Process Control efforts.
Presented by Dan Hill, Senior Manager, Process Analytical Technology at Biogen
Dan Hill is a Manufacturing Scientist with 13 years of experience in PAT development and commercialization in the pharma/biotech industry. He manages Biogen’s commercial process analytical technology (PAT) initiatives across mAB, Oral Solid Dose (OSD), and oligonucleotide manufacturing modalities. In his 5 years at Biogen, Dan has consulted and led various teams to commercialize and sustain PAT applications, including but not limited to, feedback control of glucose and metabolite monitoring in cell culture operations using Raman spectroscopy, in-line release of solutions (media/buffers) using simple sensors, rapid identification of raw materials using handheld Raman spectroscopy, and in-line sequence identification of oligonucleotides using FT-IR. Prior to his time at Biogen, Dan gained experience as a PAT/CMC Scientist at Boehringer-Ingelheim, Global Near-Infrared spectroscopy capability Manager in Cargill Inc. Corn Milling North America division, and as a chemist in Eli Lilly’s Analytical Sciences Research and Development organization.
Dan is a graduate of Ball State University, where he received a BS in biochemistry in 2007. He is completing an MBA (Spring 2020) from North Carolina State University with a concentration in Technology Commercialization Entrepreneurship (TEC).
Followed by an Industry Perspective Presented by Maryann Cuellar, Life Science Product Manager at Kaiser Optical Systems, Inc.
Maryann Cuellar is the Life Science Product Manager at Kaiser Optical Systems, Inc. She has been providing application support for pharmaceutical implementation of Raman spectroscopy for 15 years at Kaiser with recent years devoted to advancing bioprocess applications of Raman. She holds a Master of Science Degree in Analytical Chemistry with a research focus in chemometrics and process analytical technology.
Sponsored by Kaiser Optical Systems, Inc
Kaiser Raman Bioprocessing Solutions
Kaiser Optical Systems, Inc. has been at the leading edge of in situ PAT in upstream bioprocessing for over 10 years. Kaiser Raman technology is robust, scaleable, and transferable. During process development, Raman enables adoption of QbD principles to define manufacturing design spaces, optimize process conditions, and demonstrate process robustness and quality. In production, improvements to product quality and yield have been demonstrated by employing Raman-based control strategies. In recent years, Kaiser Raman successes in upstream bioprocessing have expanded into downstream and cell / gene therapy applications.