DAY 2 - Wednesday 29th February 2012

Please enable javascript to see more information on speakers

9am	Chairman’s opening remarks 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.. › Dr Sasa Stojkovic, Head of Pilot Bioprocess Department, Sandoz
	NEW TECHNOLOGIES TO ENHANCE CELL LINE EXPRESSION
9.10am	Development of an early warning system for production instability Dr Ulrich Göpfert Ulrich Göpfert is a Senior Reseach Scientist in the Cell Line and Molecule Development department at Roche. Dr. Göpfert received his Diploma and Ph.D. in Biochemistry from the University of Tübingen, Germany. In 2002 he joined the Biologics Research ... more.. How important is the early identification of the instability of specific cell lines in terms of reducing production times and costs? Exploring a new real-time qPCR which can deliver fast and sensitive measurements in multiple cell lines; effectively acting as an early warning system for production instability Will this early identification lead to other beneficial outcomes?  Will it result in better clones in terms of bioprocess robustness and productivity? › Dr Ulrich Göpfert, Senior Scientist, Pharma Research and Early Developent, Roche Pharmaceuticals
9.40am	Protein expression in CHO cells: comparison of GPEx to a traditional cell line engineering technology Mike Jenkins Dr. Michael Jenkins has been with Catalent Pharma Solutions since February 2003. He served as Director of Business Development and Commercial Operations until he was promoted to VP of BD in 2006 and General Manager in 2009. During his tenure The... more.. How big biotech evaluated and compared a proprietary cell line development technology to its internal platform Impact of technology on expression levels and stability Evaluating the lessons learned › Mike Jenkins, General Manager, Middleton, Catalent Pharma Solutions
10.10am	Exploring how improved cell line screening and selection can deliver product faster and cheaper Dr Christine DeMaria Christine DeMaria is a Senior Scientist in the Cell Line and Cell Culture Process Development group at Genzyme. Dr. DeMaria received her B.S. in Biology from Tufts University and her Ph.D. in Microbiology and Immunology from Wake Forest University... more.. Implementing high-throughput clone selection methods to reduce early stage development time by selecting the clones which are stable and express high titres Highlighting how new technologies and R&D methodologies can improve early stage development of therapeutic candidates Examine in closer detail the impact using a cell surface reporter can have on process efficiency by predicting relative expression levels of recombinant therapeutic proteins › Dr Christine DeMaria, Senior Scientist, Therapeutic Protein Expression, Genzyme Corporation
10.40am	Morning refreshments
11.10am	CHO based platforms: Enabling biotherapeutic development efficiency Dr Jonathan Dempsey Dr. Dempsey is a Process Science Fellow for Gibco’s® PD-Direct™ Bioproduction Services. He is responsible for assisting European and Indian biopharmaceutical companies in developing products and processes for the manufacture of biological... more.. Maximizing product titers through effective use of CHO based platforms Ensuring compliance standards with successful GMP cell line documentation Achieving unprecedented commercial licensing flexibility in biotherapeutic development › Dr Jonathan Dempsey, Process Science Fellow, Life Technologies
11.40am	Improving CHO cell line development with innovative platform technologies Dr Thomas Jostock Thomas graudated from the University of Mainz in Germany, where he finished his PhD thesis in the field of cytokine research in 2001. Thereafter, he joined Dyax in Liege/Belgium, focusing on high through-put re-formatting of phage library derived... more..  Where do the opportunities lie for implementing new technologies? Should cell line development methodologies be adjusted or re-written? Comparing the potential of standard technologies against that of novel vector technologies emerging onto the market How fast can cell line identification become without risking inadequate screening?  › Dr Thomas Jostock, Technology Network Leader, Integrated Biologics Profiling, Novartis
	ASSESSING MEDIA SELECTION OPTIONS
12.10pm	Rethinking the impact of next generation CD supplements on cost of goods Dr Samuel Denby Sam joined BD as Applications and Scientific Manager in 2010 having held positions at Oxford BioMedica, Medimmune and Cambridge Antibody Technology. Sam holds a BA in physiological sciences from Oxford University and an Engineering Doctorate from... more.. Evaluating qualitatively the potential benefit of chemically defined manufacturing processes Understand how the next generation chemically defined supplements offer a route to maintain high productivity levels, with peptone supplements, while gaining the advantages of a chemically defined manufacturing process Explore quantitatively how BD Recharge™, one of these supplements, may impact cost of goods › Dr Samuel Denby, Applications and Scientific Manager, BD Biosciences
12.40pm	Networking lunch
1.40pm	Dry powder mammalian cell culture media production: from easy going to sophistication - a case study DMEM / F12 production Exploring the physico chemical characterisation data of DMEM / F12 to identify the beneficial factors Batch to batch consistency: the grail in media production and supply Will media testing beyond cell growth provide significant insight for subsequent developments? Perspectives in future media preparation › Dr Aline Zimmer, Head of cellular assays development and scale-up laboratory, Merck Millipore
2.10pm	Raw material sourcing: a practical approach in today's environment Dr Marlin Frechette Over 20 years experience in the Medical Device industry serving the Pharmaceutical and Biopharmaceutical Industry. At Irvine Scientific she is currently the Management Representative with oversight to the review functions of the Regulatory... more.. Applying a risk-based approached and what it can mean to sourcing Appropriate characterization of materials integrated into quality and supply strategies Consideration of new quality requirements – a supply chain partnership › Dr Marlin Frechette, Quality Systems Director, Irvine Scientific
2.40pm	Development of a cutting edge CHO cell culture medium: Presentation on behalf of PAA Eric Kurzhals Dr. Eric Kurzhals presents a cutting edge CHO cell culture medium. Dr. Eric Kurzhals is currently Head of Process Development at Cellca GmbH. In this role he is responsible for cell culture media development and small scale process development for... more.. Evaluating the results you can achieve when combining a stringent scientific approach with state of the art industrial experience Detailed analysis of cutting edge CHO cell culture medium   › Eric Kurzhals, Head of Process Development, Cellca GmbH
3.10pm	Afternoon refreshments
	DELIVERING A ROBUST UPSTREAM PROCESS
3.40pm	How to maximize throughput and flexibility in a multi-product launch facility Dr Joachim Baer Dr. Joachim Bär is currently Head of Manufacturing Science and Technology Upstream at Boehringer Ingelheim Pharma GmbH & Co. KG, where he is supporting successful product transfers, scale up, process improvement and trouble shooting, functional... more.. Understand the bottlenecks in upstream and downstream operations to gain the maximum throughput Optimization of facility and equipment design to gain more flexibility for different products and processes How to work efficiently in flexible scales › Dr Joachim Baer, Head of Manufacturing Science and Technology Upstream, Boehringer Ingelheim GmbH & Co. KG
4.10pm	Will small-scale, high-throughput upstream processes become the standard for cell culture development? 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.. Are small-scale technologies capable of advancing the industry further?  Can they continue to reduce costs and increase productivity standards? Successful utilisation of multiple small-scale processes to allow access to cell line performance information in reduced time › Dr Matthieu Stettler, Manager USP, Biotech Process Sciences, Merck Serono
4.40pm	Can single-use bioreactors be implemented in vaccine production? 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.. Evaluating the significant benefits of disposable technologies in this role from reducing investments costs to increasing facility output   Understanding the challenges which need to be overcome due to biosafety, and the need for multiple cell lines increasing the complexity of platform technology Should viral vaccine production be carried out in disposable technologies or are the association difficulties too great? › Philippe Alexandre Gilbert, Senior Scientist, Cell Culture Development, Research and Development, Glaxosmithkline Biologicals Sa
5.10pm	Scale-up/scale-down strategies for the production of biopharmaceuticals from animal cell culture in large-scale stirred bioreactors Dr Alvin Nienow Dr Alvin W Nienow, Emeritus Professor of Biochemical Engineering at The University of Birmingham, UK is also a Visiting Professor of Biochemical Engineering at Loughborough University, UK. He has a PhD and DSc (Eng) from University College London... more.. Evaluating, through physical and biological scale-down studies, the optimal design for agitated bioreactors Analysing data showing concerns about ‘shear damage’ to be greatly exaggerated and the factors which have been overlooked as a result    Highlighting the impact poor homogeneity and build up of dissolved CO2 could have on scale-up performance   › Dr Alvin Nienow, Emeritus Professor of Biochemical Engineering, University of Birmingham
5.40pm	Close of Day 2 followed by Networking Drinks