Day 3 - Thursday 1st March 2012

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9am	Chairman’s opening remarks Dr Berthold Bodeker Dr. Berthold Bödeker is Chief Scientist and heading pilot plants and cell culture at the CMC unit of Global Drug Discovery-Biological Development of Bayer Schering Pharma AG in Wuppertal, Germany, which is responsible for the technical development... more.. › Dr Berthold Bodeker, Chief Scientist,Head Cell Culture&Pilot Plants, Bayer Pharmaceuticals
	EVALUATING NOVEL UPSTREAM TECHNOLOGIES
9.10am	What does the next generation of fermentation plant look like? Dr Berthold Bodeker Dr. Berthold Bödeker is Chief Scientist and heading pilot plants and cell culture at the CMC unit of Global Drug Discovery-Biological Development of Bayer Schering Pharma AG in Wuppertal, Germany, which is responsible for the technical development... more.. Considering the technologies currently available will it be possible to go from campaign mode to parallel products in a ballroom concept? Does the closed system layout of single-use technology reduce the risk of cross-contamination, given the parallel products application? Exploring the possibilities of a simplified, flexible facility and how this could reduce investment, start-up and operational costs and times › Dr Berthold Bodeker, Chief Scientist,Head Cell Culture&Pilot Plants, Bayer Pharmaceuticals
9.40am	Implementing metabolite profiling in bio process applications Dr Patricia Ruiz Noppinger Dr. Patricia Ruiz Noppinger studied Biology at the Universidad Complutense of Madrid, Spain, and Paris-Lodron Universität in Salzburg, Austria. In 1994 she received her PhD from the Basel Institute for Immunology in Basel, Switzerland. Following... more.. How do broad and targeted profiling (e.g. cell energy and proliferation status) methods enable specific hypothesis driven approaches, i.e. the identification and removal of potential bottlenecks and feedback inhibition, to optimize yields and control costs? How to target optimal bio process conditions from high level analysis towards time course resolution of individual key metabolites and overall biochemical pathway architecture? What are sensitive and smart data interpretation and integration strategies of metabolite profiling in bio processing? › Dr Patricia Ruiz Noppinger, Lead Scientific Affairs, Metanomics Health GmbH
10am	Utilising technology to establish a robust fermentation process Dr Tim Noetzel Tim is currently Manager of Fermentation for Roche Pharma Biotech Production in Penzberg, Germany. In this role he leads a team responsible for seed train cultivation, fermentation process analytics and serves as responsible production process... more.. How important is it to understand how operational parameters affect fermentation? Can current technologies deliver data which is significantly reliable to make confident decision? What effect does using the Cedex Bio have on overall process efficiencies in the short and long term? › Dr Tim Noetzel, Manager of Fermentation, Roche Pharmaceuticals
10.30am	Panel discussion: delivering a robust, yet flexible upstream process Dr Matthieu Stettler Matthieu Stettler obtained a master degree from the ETH in Switzerland and joined the lab of Prof. Wurm at the EPFL in Switzerland to work on his thesis project in cell culture process development. In 2008, he joined Lonza Biologics in the UK where... more.. Dr Tim Noetzel Tim is currently Manager of Fermentation for Roche Pharma Biotech Production in Penzberg, Germany. In this role he leads a team responsible for seed train cultivation, fermentation process analytics and serves as responsible production process... more.. Dr Berthold Bodeker Dr. Berthold Bödeker is Chief Scientist and heading pilot plants and cell culture at the CMC unit of Global Drug Discovery-Biological Development of Bayer Schering Pharma AG in Wuppertal, Germany, which is responsible for the technical development... more.. Philippe Alexandre Gilbert Born in Quebec City (Canada), Dr. Philippe-Alexandre Gilbert is a graduate of the department of biochemistry at the University of Ottawa . He pursued his education at Laval University where he obtained his masters degree in molecular biology and... more.. Can the upstream processes become reproducible and efficient by utilising currently available bioreactor technologies? Highlighting the challenges of process scale-up, and identifying future strategies to deliver a reproducible production cycle What abilities does the next generation of bioreactor require if the cell culture industry is to continue to grow? › Dr Matthieu Stettler, Manager USP, Biotech Process Sciences, Merck Serono › Dr Tim Noetzel, Manager of Fermentation, Roche Pharmaceuticals › Dr Berthold Bodeker, Chief Scientist,Head Cell Culture&Pilot Plants, Bayer Pharmaceuticals › Philippe Alexandre Gilbert, Senior Scientist, Cell Culture Development, Research and Development, Glaxosmithkline Biologicals Sa
	PROCESS SCALE-UP AND SCALE-DOWN CHALLENGES
11.10am	Morning refreshments
11.40am	Exploring strategies to improve control and reduce variability Dr Sasa Stojkovic Dr. Sasa Stojkovic (36) is heading the bioprocess pilot department at the Sandoz Biopharmaceuticals Business Unit at Lek Pharmaceuticals in Menges, Slovenia, which is responsible for the bioprocess development, scale up and process transfer to... more.. Designing a scale-up process which delivers consistency to prevent the need for extensive redevelopment at such a late downstream stage Highlighting the need for technologies which can monitor parameters throughout bioproduction to allow increased control and understanding of the process Developing a systematic approach to reduce and control process variability › Dr Sasa Stojkovic, Head of Pilot Bioprocess Department, Sandoz
12.10pm	Can scale-up and scale-down ever be truly predictable? Dr José Gomes José is a biochemist & biophysicist with considerable experience in cell culture, chemical engineering, and molecular biology including 15 years of industry experience. He joined Pfizer through the acquisition of Wyeth and currently holds the... more.. How important is gaining overall performance understanding and can a QbD approach achieve this to a sufficient level? Gaining insight into the benefits and difficulties of applying predictable scale-up and scale-down models to achieve process characterisation Can meaningful results be obtained by defining an engineering design space?    › Dr José Gomes, Principal Scientist and Manager, Bioreactor Process Development, Pfizer
12.40pm	Tools for the integration of fermentation and DSP Prof Nigel Titchener-Hooker PROFESSOR NIGEL TITCHENER-HOOKER heads the Department of Biochemical Engineering at UCL where he directs the Centre for Innovative Manufacturing of Emerging Macromolecular Therapies. The Centre goals is to accelerate the development of... more.. Operating cell culture and DSP independently results in below optimal overall outputs – can integration improve the situation Exploring the application of ultra scale-down (USD) tools for the characterisation of the early stages of mammalian cell processes with an emphasis on understanding how USP changes impact later levels of purification and resolution Outlining possible strategies to dovetail the early stages of processing to reduce process complexity whilst minimising the burden of contaminants and impurities  › Prof Nigel Titchener-Hooker, Head of Department and Director, The Advanced Centre for Biochemical Engineering, University College London
1.10pm	Networking lunch
2.10pm	Importance of end of run studies for a commercial cell culture process Sofie Goetschalckx I have joined Pharming in 2000 as part of the R&D organization and shortly after Genzyme’s acquisition; I became jointly responsible to start up a cell culture team and to equip the new laboratories. I have played an important role in the... more.. Challenges to tackle during scale up of a commercial cell culture process Improve process understanding by performing studies at scale without impacting the cell culture run. What can you learn from end of run studies to improve cell culture performance and bioreactor design? › Sofie Goetschalckx, Manufacturing Cell Culture Science Lead, Genzyme
	INNOVATIVE DOWNSTREAM PROCESS TECHNIQUES
2.40pm	Exploring alternative technologies to refine downstream processes Dr Philine Dobberthien Dr. Philine Dobberthien is associate director in the Protein Science group of Boehringer Ingelheim Biopharmaceutical Division. Her team covers the development of economic and robust purification and formulation processes for mAb and non-mAb... more.. Highlighting the challenges which result from higher product titres and demonstrating where conventional purification methodologies are falling short Can downstream processes become significantly faster, or are they the rate limiting process? What impact can utilising innovative technologies have on delivering a more robust and economically sustainable downstream process? › Dr Philine Dobberthien, Associate Director Process Science, Boehringer Ingelheim
3.10pm	Addressing the future downstream processing challenges today Dr Virginie Fabre “Virginie Fabre is currently Head of Unit in the Downstream Process Development department at sanofi pasteur (Marcy l’Etoile, France). She is responsible for the development of purification processes for recombinants proteins expressed in bacterial... more.. Which part of the downstream process is the least understood and what are the current consequences? Exploring the impact thorough characterisation could have on the designing of downstream processes: including potentially identifying the source of impurities and the impact of process inputs Exploring these challenges through case studies which highlight the opportunities for improvements › Dr Virginie Fabre, Head of Purification Unit, Bioprocess R&D, Downstream Process, Sanofi Pasteur
3.40pm	Utilising process characterisation to improve downstream processes Prof Alois Jungbauer Professor Jungbauer is a University Lecturer for Protein technology and Downstream processing. His teaching activities at the University, as well as in numerous workshops around the world focus in the area of protein production, isolation and the... more.. Which part of the downstream process is the limiting factor and what are the current consequences? How early in the overall production cycle should the downstream processes be considered? Will process miniaturisation improve reliability and cost implications? › Prof Alois Jungbauer, Protein technology and Downstream Processing, European Federation of Biotechnology (also editor in chief of Biotechnology journal]
4.10pm	Close of Congress