NNE Pharmaplan’s customer topic day “Biotech facilities of the future” 5-6 November 2014 – Montreux/Bulle 5 November 2014 19:00 Reception and dinner at Eurotel Montreux 6 November 2014 09:00 Breakfast reception at Eurotel Montreux 09:20 Welcome speech Stefan Berg/Corporate Vice President, Central Europe, NNE Pharmaplan Stéphanie Sénéchal/Office Manager Montreux, NNE Pharmaplan 09:30 Introduction to the programme Gert Moelgaard/Corporate Vice President, Strategic Development, NNE Pharmaplan 09.40 Future outlook and trends in the biotech industry Gert Moelgaard/Corporate Vice President, Strategic Development, NNE Pharmaplan 10:20 Flexible biopharmaceutical manufacturing Dr. Philipp Eberhardt/Senior Project Engineer, NNE Pharmaplan 11:00 Coffee break 11:15 The new biotech production facility of UCB in Bulle Jean-Luc Roulin/Senior Project Director, UCB Stéphanie Sénéchal/Office Manager, Montreux, NNE Pharmaplan Friedrich Behrens/Senior Project Engineer, NNE Pharmaplan 12:30 Lunch 13:30 Transport to UCB facility 14:30 Arrival at UCB facility Welcome speech Amer Jaber/ VP Bio Development & Operations, GM, UCB Farchim Facility tour and wrap-up 17:00 End of facility visit, transport back to Montreux SPEAKERS AND LECTURES Gert Moelgaard is Corporate Vice President for Strategic Development in NNE Pharmaplan. He has more than 25 years experience, is engaged in several major consulting, engineering, automation and validation projects within pharmaceutical manufacturing and is actively involved in several international conferences on automation, process optimisation, GMP, qualification and validation. Future outlook and trends in the biotech industry Biopharmaceutical manufacturing is undergoing significant changes at the moment. Technology opportunities, product changes, regulatory changes and new cost pressure, just to mention a few. This can be both a challenge and an opportunity, depending on how you and your company look at it. The presentation will cover some of the changes and the opportunities for biopharmaceutical facilities of the future – both for existing and new facilities. It will cover flexible solutions, new technology opportunities and some of the regulatory challenges in an European perspective. Maybe it is time to re-think manufacturing and make investment decisions that prepare biopharmaceutical facilities for the future. Dr. Philipp Eberhardt graduated in Technical Biology (University Stuttgart). After his studies he made his Ph.D. at University Karlsruhe. His main research was in the aspects in lab on chip applications. He is responsible for the planning and implementation of biopharmaceutical processes, specialized on applications with single-use technology. He joined NNE Pharmaplan AG in Basel in February 2009. Flexible biopharmaceutical manufacturing The biotech segment is rapidly developing. Monoclonal antibodies, vaccines and personalised therapies will further drive the fractionation of the biopharmaceutical market, thus increasing the need for smaller batch sizes and campaign-based production schemes. New biopharma manufacturing facilities have to be smaller, more flexible and more cost-effective. New technologies like single-use systems can provide productive and cost-effective processes in a fast and predictable way and able to adapt quickly to changes in market demand. Jean-Luc Roulin is chemical engineer with broad experience in the biotech industry, although principally orientated towards manufacturing operations. His field of experience includes tech transfers, scale-up, engineering, QA/RA, CMO and project management. He has held senior positions at Merck Serono as Biotech Manufacturing Director in charge of production of marketed drug substances. Since 2009 he is working at UCB where he first led the biotech Center of Expertise in charge of biotech CMO management. Currently, he is heading the Edelweiss project at UCB, Bulle. The scope of this project is to cover the construction of a greenfield biotech plant, the design and installation of the process/utilities equipment including 3 fermenters of 15kL, the qualification of the plant equipment as well as process validation. Stéphanie Sénéchal has more than 14 years of good manufacturing practice (GMP) and validation experience in the biotech and pharmaceutical industry. After 4 years spent in pharmaceutical production (filling and packaging lines), she continues her career by focusing on the implementation of quality management systems. She has extensive knowledge of current good manufacturing practice (cGMP) guidelines and drug regulation issued by food and drug administration (FDA) and/or local European medicines agencies. She joined NNE Pharmaplan France in 2007 and is Office Manager for Romandie since February 2010. Friedrich Behrens graduated at the University of Applied Sciences Ostwestfalen-Lippe specialised in pharma and biotechnological engineering. Additional focus during his studies was in the field of gene technology, quality management and process management. He is Senior Project Engineer in NNE Pharmaplan and has 10 years experience in several major investment projects as process engineer and as coordinating space manager in Switzerland. He acted as process manager on the UCB Edelweiss project. The new biotech production facility of UCB in Bulle UCB, as a global biopharmaceutical company, is focused on the discovery and development of innovative medicines and solutions to transform life of people living with several diseases of the immune system or the central nervous system. Since some years, UCB has successfully transformed from a hybrid speciality chemical company into a next generation Bio Pharma leader. After having invested in a new biotech pilot plant in Belgium, UCB decided to invest in a new greenfield biotech facility in Switzerland, Bulle, in order to produce Cimzia®. This investment had an ambitious time schedule. To succeed in, the UCB Project Management team had to make strategic decisions: - Fast track approach - Implementation of ASTM E2500 - Cross disciplinary teams from different nationalities The conceptual design started on 30 June 2011. 2014 is the ramp up’s year. Let’s discover the exciting journey of the UCB Edelweiss project!
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