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Center for Biopharmaceutical Operations Workshop
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May 21, 2008: Establishing a Research Agenda in Bioproduction |
On May 21 2008, UC Berkeley held its second major Bioproduction Workshop, examining critical issues in Biopharmaceutical Operations. This one-day workshop featured over 80 delegates from Industry and Academia, and set the research agenda for UC Berkeley's Center for Biopharmaceutical Operations.
Pat Yang, Executive Vice President of Product Operations at Genentech, was the keynote speaker at the conference.
Industry representatives on the workshop discussion panel included:
Joerg Heidrich, Senior VP, Global Head of PS Biotech, Bayer HealthcareChris Horan, Senior VP, Global Supply Chain Planning, Distribution and Logistics, Genentech
Andy Rammelmeier, VP Manufacturing and Process Development, BiomarinBrian Maiorella, adjunct Professor at UC Berkeley, retired VP of Process Development at Chiron
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| Background |
Since its inception, the biotechnology industry has had strong ties with UC Berkeley. This mutually beneficial collaboration between industry and academia continues to this day, primarily in the areas of research and development of new biopharmaceutical medicines.
In contrast to the primarily R&D focus of this relationship, other industries – including the semiconductor industry - have participated in academic-led centers focusing on operations. These centers have focused on pre-competitive manufacturing and logistics research, as well as benchmarking of operations. Such academic ‘Centers of Excellence’ have been pivotal in providing efficiency gains and increasing the sophistication of operations within these industries. For example, the Competitive Semiconductor Manufacturing Program at UC Berkeley led to the identification, development, and promotion of world-class semiconductor manufacturing practices throughout that industry.
The current environment of increasing costs and other efficiency pressures within the biopharmaceutical industry are creating the need to take a quantum leap forward in biopharmaceutical operations management. UC Berkeley’s has been developing the Center for Biopharmaceutical Operations (CBO) to bring together academic researchers with diverse expertise and industrial experience and biopharmaceutical professionals. The goal of the CBO is to advance the state of the art of biopharmaceutical operations. The focus is on cost-effective, reliable biopharmaceutical production systems and supply chains. Our goals include:
• Facilitating collaboration between academia and industry
• Conducting biopharmaceutical operations benchmarking studies
• Establishing projects to improve the current body of research and operational performance in industry
• Developing and providing educational seminars
• Providing industry with world class employees
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For further information about the Workshop please email organizer Rick Johnston rickj@berkeley.edu or Professor Phil Kaminksy: kaminsky@ieor.berkeley.edu. |
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2008 Workshop Presentations
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The first Berkeley Biomanufacturing Workshop was held on February 7, 2006, with the goal of initiating the exploration of key issues in biopharmaceutical manufacturing. In addition to academic participants, representatives of various groups and divisions of Chiron Corporation, Genentech, and Bayer HealthCare participated in the workshop. After several hours of presentations, three breakout groups met to discuss operational control, short range planning, and long term planning. A brief discussion of the outcomes of the three breakout groups follows:
• Operational Control of Bioproduction: A variety of key focus areas related to operational facility control were discussed, including issues related to process robustness, scheduling and rescheduling of operations, quality control and the manufacturing/QC interface, maintenance and maintenance scheduling, process variability, manufacturing control decisions, and risk vs. profit analysis.
• Short-Term Planning of Bioproduction: Attendees discussed opportunities and complicating factors in the areas of demand planning, supply planning, and inventory planning. Demand planning opportunities include enhanced demand forecasting to deal with a variety of complicating factors included regional issues, issues with distributors, and the interpretation of sales forecasts. Supply planning could involve enhanced methods of scheduling batches through factories, and is complicated by biologic process risk, equipment and operator errors, yield and cycle time variability, communication difficulties, and manufacturing constraints. Attendees recognized the need to develop integrated systems and structured methodologies for planning and re-planning, to enable benchmarking and what-if analysis. In the area of inventory planning, attendees discussed the need for an analytical basis for quantifying risk and understanding cost/risk tradeoffs.
• Long Range Planning: Attendees discussed the need to effectively model uncertainty, innovation, and hedging strategies in the presence of complex product structures, evolving risks, a variety of sources of non-stationing uncertainty, and the growing influence of and reliance on contract manufacturers. The value of flexibility and standards was also considered.
Additional information and presentations from this workshop are available at the bottom of this page.
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A Workshop Report will appear soon in this space. Until that report is ready, we've posted notes from breakout groups and the panel discussion in the Workshop Materials space. |
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