Modern Approaches to Process Understanding

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1 Biomanufacturing and Process Development (BPD) Modern Approaches to Process Understanding Thursday, September 18, :00 pm - Registration begins 1:15 5:00 pm - Presentations & Networking North Carolina Biotechnology Center Program Organizers: Barney Crum, barney.crum@roche.com Gary Gilleskie, gary_gilleskie@ncsu.edu EVENT SPONSORED BY

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3 AGENDA 1:00 1:15 pm Registration 1:15 1:30 pm Introductory Comments How Today s Expectations and Tools for Process Understanding Differ from 10 Years Ago Gary Gilleskie, North Carolina State University 1:30 2:10 pm In Situ Monitoring of Cell Culture Exit-gases Through Novel Process Analytical Technology Kevin Chang, Biogen Idec 2:10 2:50 pm Accelerating Cell Culture Process Development Shahid Rameez, KBI Biopharma 2:50 3:30 pm Networking 3:30 4:10 pm Quality By Design and the Use of DOE as a Right First Time Approach to Process Development and Risk Reduction in Downstream Manufacturing Mark Wilson, Novartis Vaccines and Diagnostics 4:10 4:50 pm "High Throughput Analytics to Enhance Efficiency and Economics in Bioprocessing Yixin Lin, Pall ForteBio, LLC 4:50 5:00 pm Closing comments

4 ABSTRACTS Kevin Chang Engineer II (Pilot Plant Cell Culture in Cambridge) Biogen Idec In Situ Monitoring of Cell Culture Exit-gases Through Novel Process Analytical Technology" Abstract: Biogen IDEC (BIIB) is focusing on designing and developing new state of the art technologies that will enable real-time process control aiding advanced control algorithms that generate company value by increasing productivity, process consistency, and product quality to internal programs. One of the BIIB Advanced Process Control (APC) projects is evaluating the novel way of collecting cell culture off-gas. The off-gas from the bioreactor has been an undefined area in the biotechnology industry due to complexity and lack of advanced technologies. Current process analytical technologies mostly focus on liquid-phase components such as glucose, lactate, cell density, and titer. However, the gas-phase components from the bioreactor can be very important in terms of scale-up, feed strategies, and biomass. The FDAs mandate on process analytical technology improvements in bioprocessing makes this an obvious application area that should be explored. Optograf analyzer presents an innovative way of using spectroscopy to measure the composition of exhaust gasses associated with bioprocessing, creating a complete mass balance around the system. It is a more robust offgas PAT tool than the traditional electrochemical sensor gas analyzer. In terms of operation, Airhead probe from the Optograf analyzer (Kaiser Optical Systems, Inc.) is easier to implement as the associated probes are simply placed in the bioprocess gas lines and eliminate the requirement for sensor/membrane replacement and complicated calibration protocols associated with traditional off-gas analyzers. Optograf uses the technology of Raman spectroscopy which is a form of infrared vibrational spectroscopy with theoretical basis described by the shift in energy levels of molecular bonds upon excitation from a higher energy source. The Optograf will not only lead to more precise calculations of the Oxygen Uptake Rate (OUR) and Carbon Dioxide Production Rate (CPR) by measuring the differences of sparge and exhaust oxygen and carbon dioxide, but may also be able to track unknown off-gas species which will unravel a novel field in mammalian cell culture. Bio: Kevin received a BS in chemical engineering from the University of California, San Diego. He has worked at Biogen Idec for about 6 years, focusing on the area of cell culture. He began his career at Biogen Idec in small-scale cell culture, working on developing chemically defined media for high titer processes. He later joined the pilot plant cell culture group, where he supports manufacturing scale up and the use of advanced process control technologies.

5 ABSTRACTS Shahid Rameez, Ph.D. Senior Process Development Scientist KBI Biopharma Inc. Accelerating Cell Culture Process Development" Abstract: Decreasing the timeframe for cell culture process development has been a key goal towards accelerating biopharmaceutical development. The data presented here will help to demonstrate the utility of high throughput miniaturized bioreactor system (ambr) in accelerating cell culture process development. Through various case studies conducted at KBI Biopharma we will demonstrate on how these high throughput bioreactors are used to study effects of various process parameters on cell growth, productivity and product quality. In addition, we will present some case studies demonstrating incorporation of these bioreactors to study optimization of process design space and effect of process control perturbations. Bio: Shahid is a process development team leader at KBI Biopharma Inc. As a team lead he works on all the CMC activities responsible for developing cell culture processes (inhouse and for the clients). Shahid's expertise is in scale-up/scale-down, technology transfer, high-throughput cell culture development and analytics. Shahid Rameez received his PhD in Biochemistry program (Department of Chemical Engineering) from The Ohio State University in Prior to joining KBI in 2012, he was a Postdoctoral Research Fellow in the Department of Chemical Engineering at The Ohio State University. Shahid has over 8 publications in the area of protein therapeutics and process development.

6 ABSTRACTS Mark Wilson, Ph.D. Senior Manager, Downstream Technical Development Novartis Vaccines and Diagnostics Quality By Design and the Use of DOE as a Right First Time Approach to Process Development and Risk Reduction in Downstream Manufacturing Abstract: Quality by Design and the Use of DOE as a Right First Time Approach to Process Development and Risk Reduction in Downstream Manufacturing: QbD is an ICH initiative that Regulatory Authorities expect to be used by industry in drug development This presentation seeks to explain what QbD means at Novartis and how we implement it What does it mean to the science and what experiments do we need to do? Finding out about interacting factors and building the design space is a key part of QbD What is Design Space and how do we develop it? Case studies in the use of statistical design are presented QbD and DoE are used from the outset in screening studies, throughout the lifecycle and into commercial manufacture The knowledge and understanding gained is a sound foundation for robust, reliable manufacture with reduced risk Bio: Mark Wilson has worked in biotech process development for over 25 years. He has experience working at small biotech and large pharma companies, and with products as diverse as live virus vaccines, protein sub-unit vaccines, therapeutic proteins and antibodies. His experience spans the project lifecycle from Research to Launch. Mark has been using Design of Experiments since 1998 and has seen the gradual progression of Quality by Design over the last decade to where it is now an expectation of the Regulatory Authorities. Mark is an advocate of ensuring that Development provides a robust, reliable process to Manufacturing that delivers high quality product to the patient with minimal risk of batch failure. Mark holds a BS and PhD from University of Kent and subsequently worked for 20 years in the UK. Mark moved to the US in 2009 and now works at Novartis Vaccines as Senior Manager, Downstream Technical Development.

7 ABSTRACTS Yixin Lin, Ph.D. Technical Support Scientist Pall ForteBio, LLC High Throughput Analytics to Enhance Efficiency and Economics in Bioprocessing Abstract: To address the needs of a large number of biotherapeutic molecules and vaccines in development, it has become increasingly important for biopharmaceutical companies to adopt a new generation of high throughput (HT) analytical techniques to facilitate fast and accurate characterization and processing monitoring. Recent advances in the use of Bio-layer Interferometry (BLI) are described for monitoring biotherapeutic molecules through quantitation and functional characterization, with emphasis on new development/methods in bioprocessing. The approaches offer benefits of label-free, real-time monitoring, enhanced throughput, decreased sample preparation requirements, and low cost of operation. Bio: Yixin Lin is a technical scientist from Pall ForteBio, LLC. Yixin has been with Pall ForteBio for 4 years. Previously she worked as a field application scientist in various life science companies for more than 10 years. She holds a Ph.D. degree from Cornell University in biochemistry and has just recently moved to North Carolina from New York State.

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9 Notes

10 Program Schedule Season Month September 18, 2014 Program PAT/QbD Symposium Modern Approaches to Process understanding (upstream and downstream ) NC Biotechnology Center October 23, 2014 November 13, 2014 January 2015 February 19, 2015 (Feb 24 snow day) March 10, 2015 April 11, 2015 April 16, 2015 May 14, 2015 Continuous Process Symposium NC Biotechnology Center Analytical Symposium & Vendor Show (Drug Product Theme Formulation, Devices, Analytical Testing or Analytical / Formulations - could include CROs) NC Biotechnology Center Manufacturing Facility Tour Date and location TBD Single Use Symposium & Vendor Show NC Biotechnology Center 22nd Annual ISPE-CaSA Life Sciences Technology Conference Raleigh Convention Center 500 S. Salisbury Street, Raleigh, NC (sponsorships available through ISPE Early-Bird Exhibitor Deposit Form) Triangle SciTech Expo (aka Best Fest ) NC Museum of Natural Sciences 11 W Jones St, Raleigh, NC Quality/Regulatory Symposium NC Biotechnology Center New Frontiers Symposium and Expo NC Biotechnology Center **Monthly Meeting and Vendor Sponsorship Packages available, request information**

11 Biomanufacturing & Process Development Group An Intellectual Exchange Group of the North Carolina Biotechnology Center Mission and Goals BPD s mission is to provide a forum for process development scientists and engineers to discuss bioprocessing issues. The group meets approximately six to seven times a season/year with speakers from academia, industry, technology vendor experts, and regulatory experts. Membership Guidelines Faculty, students, postdocs and industry members with interest in BPD are welcome. Meeting Format Similar meeting format as previous years will be maintained in the season. Each event will host multiple speakers centered around the event theme, allow a time for networking among attendees, and optionally include a vendor show or poster presentations. Sponsorships Monthly meeting and vendor sponsorship packages available. Please contact Brian Nunnally, Brian.Nunnally@biogenidec.com at or Dhaval Tapiawala, dhaval.tapiawala@fujifilmdb.com at for additional information. For More Information Brad Kosiba, BK Collaborative, LLC brad.kosiba@bkcollaborative.com Cricket Megarity, Pfizer Christine.megarity@pfizer.com

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