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Pre-congress briefing – Tuesday 12th September
Bioscience underpinning bioprocessing
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| 08.00 | Registration and coffee
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| 09.00 | Chairman’s opening remarks
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| | Confirmed: Florian Wurm, Professor of Biotechnology, Swiss Federal Institute of Technology Lausanne (EPFL)
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| 09.10 | Keynote address: mammalian cell culture based manufacturing - the interaction of DNA, cells, reactors and process
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A need for a greater systems-based understanding of biology for improved bioprocessing
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How cell biology and metabolism link to process performance
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Cellular and molecular processes which control or limit function and performance relevant to bioprocessing
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Knowledge limitations of cellular mechanisms that control the performance of biological systems in vitro |
| | Confirmed: Florian Wurm, Professor of Biotechnology, Swiss Federal Institute of Technology Lausanne (EPFL)
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| 09.50 | Understanding, controlling and manipulating metabolism in microbial fermentation
- Developing an improved understanding of cell physiology and cellular processes so as to improve the efficiency of bioprocesses
- What factors limit the productivity of cells?
- How can we control and manipulate cellular processes so that bioprocess efficiency is improved both upstream and downstream?
- The underlying biological properties that define the process characteristics of cells
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| | Confirmed: Rainer Fischer, Department Head, Fraunhofer Institute for Molecular Biology & Applied Ecology
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| 10.20 | Morning coffee
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| 11.20 | Case study: synthetic biology for bioprocessing
- Synthetic biology, more than just biological science
- Crossing engineering and computer science approaches with biology
- Opportunities presented by synthetic biology
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| | Confirmed: Sven Panke, Assistant Professor Bioprocess Engineering, Swiss Federal Institute of Technology Zurich (ETHZ),
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| 11.50 | Panel session: investigating biological systems at the molecular and cellular level
- Limitations of cellular mechanisms controlling the phenotypic function or performance of biological systems
- Current state-of-the-art technologies which investigate the molecular mechanisms at play at each stage throughout the cellular process
- Identification of the molecular systems involved in each component of a process
- Clarification of the nature of any interactions and the molecular control mechanisms governing these
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| | Moderator: Florian Wurm, Professor of Biotechnology, Swiss Federal Institute of Technology Lausanne (EPFL) Confirmed: Rainer Fischer, Department Head, Fraunhofer Institute for Molecular Biology & Applied Ecology Confirmed: Sven Panke, Assistant Professor Bioprocess Engineering, Swiss Federal Institute of Technology Zurich (ETHZ),
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| 12.30 | Lunch
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| 14.00 | Case study: model-based control and optimisation of mammalian cell culture processes
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A biological systems engineering approach to developing models of animal cell culture systems
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Development of dynamic structured models for mammalian cell culture systems through parallel experimentation
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Effect of environmental conditions (especially at scale up) on cell physiology and productivity
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Utilisation of genomics to elucidate the intricate relationships between environmental bioprocess conditions and gene expression and function |
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| 14.30 | Systems biology of recombinant organisms
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Identification of metabolic engineering targets for increasing the production of recombinant products
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Construction of detailed mathematical models of recombinant organisms and application of nature-inspired optimisation methods
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High throughput techniques for the identification / validation of biological models |
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| 15.00 | Impact of genomic information and cellular network analysis on bioprocess development
- Improved understanding of the properties of proteins and protein chemistry aiding development
- The need to understand and predict protein pharmaceutical performance
- The molecular, genetic, and metabolic processes involved in the growth of cells and the expression of cellular products
- Structure/function relationships in the use of proteins for biochemical conversions
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| | Confirmed: An-Ping Zeng, Professor and Institute Head/Research Group Systems Biology, Hamburg University of Technology/German Research Center for Biotechnology, Germany
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| 15.30 | Afternoon tea
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| 16.15 | Case study: the challenge of protein aggregation
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On the mechanisms of protein aggregation
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Transitory aggregates
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Protein aggregates in drug substances
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Protein aggregates in drug products
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New methods to study and quantify protein aggregates |
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| 16.45 | Panel session: cellular and molecular processes influencing strategies for process design and metabolic engineering
- Predicting the impact of molecular characteristics on processing decisions, performance and product properties
- The impact of cellular characteristics on processing – gaining knowledge directly pertinent to a bioengineered system
- Utilising quantitative data streams derived from more than one level of cellular organisation
- Generating strategies derived from experimentally verifiable predictive models
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| | Moderator: Florian Wurm, Professor of Biotechnology, Swiss Federal Institute of Technology Lausanne (EPFL) Confirmed: An-Ping Zeng, Professor and Institute Head/Research Group Systems Biology, Hamburg University of Technology/German Research Center for Biotechnology, Germany
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| 17.30 | Chairman's closing remarks
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Congress day one – Wednesday 13th September
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| 08.00 | Registration and coffee
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| 09.00 | Chairman’s opening remarks
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| STRATEGIES FOR PROCESS DESIGN AND ENGINEERING |
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| 09.10 | Opening address: linking bioscience with business and process models to improve biopharmaceutical development
- The industry faces unprecedented pressures to achieve speed to market and process economy
- Advances in life sciences combined with a rigorous engineering and business framework can help to realise these goals
- Academics and industrials have collaborated in a unique consortium (Innovative Manufacturing Research Centre) to research the potential of harnessing such technologies
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| SCALE UP FOR FERMENTATION AND CELL CULTURE |
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| 09.40 | Speed-to patient/market as a key for success
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Industrial bench marking: cDNA to MCB (Mammalian Cell Line Expression Systems)
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Overview of traditional expression systems
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Current available technologies to improve
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Out-look 2010 |
| | Confirmed: Hans-Peter Knopf, Head, Protein Expression Technologies, Novartis Pharma
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| 10.10 | Morning coffee
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| 11.10 | Multi-speaker panel session: achieving expression of biopharmaceuticals
Case study: achieving high-level process development in mammalian protein expression
- Current standards in mammalian cell expression technology
- Approaches to cell screening; developments in fed batch culture
- Optimising expression systems to aid in protein recovery and to improve overall yields and efficiencies
- Challenges presented in mammalian systems
Prof John Birch, Chief Scientific Officer, Lonza Biologics, UK
Case study: scaled up protein production by microbial fermentation
- Overview of microbial fermentation and the kinetics of fermentation
- Protein expression in bacteria and computer control of fermentation
- Fundamentals of microbial growth, growth kinetics, strain development, and scale-up strategies
- Scale-up strategies and media formulation in fermentation processes
Dr Bo Kara, Head of Expression and Cell Sciences, Avecia, UK
Case study: plant cell fermentation for the scale-up production of recombinant proteins
- Initiating fermentation and cell culture scale-up during pre-clinical and clinical phases
- Scale-up fermentation and cell culture during different clinical and commercial stages
- Examples of recombinant protein scale-up from plant cell suspension cultures
- Improving yield of recombinant proteins in plants
Dr Stephan Hellwig, Fraunhofer Institute for Molecular Biology and Applied Ecology, Germany
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| 12.10 | Case study: upscaling strategies in recombinant manufacturing
- Technology transfer to ensure an effective upscaling process
- Critical factors and timelines for a successful technology transfer of a microbial process - multiscale strategies from 3,000 L to 40,000 L
- Technical and regulatory requirements for upscaling to different scales at multipurpose facilities
- Case study: comparison of results of a recombinant product, manufactured at 3,000 L, 13,000 L and 40,000 L scale
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| 12.35 | Lunch
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| 14.05 | Case study: strategies for achieving acceptable cost of goods: microbial fermentation
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| ADVANCING BIOPROCESS DEVELOPMENT |
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| 14.30 | Case study: fast-track process development for industrial plasmid DNA production
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Setting standards for industrial plasmid DNA manufacturing
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Critical success factors for plasmid production
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Generic platforms applicable for any product
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Measures to reduce development time and costs
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Addressing pandemic disease threats by cutting lead time |
| | Confirmed: Hans Huber, Technology Agent - Biopharmacetuical Production, Boehringer Ingelheim Austria
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| 14.55 | Speed networking
- Meet….move on….meet….move on….meet!
- Exchange business cards with fellow conference delegates, speakers and moderators
- The best 50 minute networking session you’ve ever experienced
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| 15.45 | Afternoon tea
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| 16.15 | Scale up with an advanced high-throughput micro-bioreactor experimentation system
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Scale down system requirements
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Common design concerns with large-scale bioreactors
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Scale-down followed by scale-up predicaments
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Key parameters for process development and commercialisation |
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| 16.40 | Case study: use of disposable technology in biologics manufacture
- Problems arising from fast track technology transfer of an antibody production process
- How to adapt an outdated microbial fermentation facility for mammalian cell culture
- Impacts and advantages of using disposable technology
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| 17.05 | Overcoming challenges in biopharmaceutical scale-up to production
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Outstanding challenge of cell line development, media formulation, fed-batch process definition and scale-up
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Enabling tools and technologies, novel approaches and practices for speedy and efficient process development, optimisation and scale-up
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Improving integration with downstream processing technologies
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Benchmarking and best practice to improve culture productivity while ensuring product quality |
| | Confirmed: Daniel Vellom, Associate Director of Purification Development, Acambis
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| 17.30 | Chairman’s closing remarks and close of congress day one
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| 17.40 | Networking cocktail reception
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Congress day two – Thursday 14th September
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| 08.00 | Registration and coffee
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| 09.00 | Chairman’s opening remarks
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| | Confirmed: Avinoam Kadouri, Consultant, Manufacturing, Laboratoires Serono S.A.
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| ENABLING SCALE-UP IN DOWNSTREAM PROCESSES |
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| 09.10 | Keynote address: assembling a bio-downstream process to produce an efficacious bioproduct
- Bio-downstream process design concerning process optimization, economics and regulatory bioproduct requirements
- Innovative, process solutions enabling scale-up in downstream processing
- Examining pre- and post-processing unit operations
- Studying downstream processes using simulation strategies to explore component compatibility
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| | Confirmed: Thomas Smith, Director, Downstream Process Development, GlaxoSmithKline R&D
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| 09.40 | Case study: design and scale-up of downstream processing of Monoclonal antibodies (Mabs)
- Selecting resins to optimize bioseparation processes
- Designing economical purification strategies
- Large-scale column packing; packing methods and troubleshooting
- Successful scaling-up bioseparation processes
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| | Confirmed: Lothar Jacob, Marketing Manager Process Separations, Merck KGaA
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| 10.10 | Morning coffee
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| 10.55 | Multi-speaker panel session: bioprocessing system scale-up for protein purification
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Integrated process development strategy from small to large scale
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Development of robust and economic downstream processes in the light of high protein amounts
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Process scenarios for antibodies in comparison to recombinant proteins
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High throughput tools and techniques for the rapid, cost effective design and development of new purification processes |
| | Moderator: Avinoam Kadouri, Consultant, Manufacturing, Laboratoires Serono S.A. Confirmed: Gianni Baer, Scientific Director, Laboratoires Serono SA Confirmed: Wil van Haren, Director, Large Scale Downstream Processing, Diosynth Biotechnology
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| 11.55 | Multi-speaker panel session: bioprocessing system scale-up for protein purification
- High Throughput tools and techniques for the rapid, cost effective design and development of new selective capture technologies for purification of new products
- Process scenarios for recombinant proteins and antibodies
- Basics of validation and how they impact process design
- Process requirements and analytical techniques used to judge quality in manufacturing
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| 12.25 | Case Study : Enabling the robust design and scale-up of an antibody capture chromatography process
- a solution for the monoclonal antibody production bottleneck
- the flexibility of a high performance rPA chromatography media
- process modeling of rPA capture chromatography unit operations
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| | Confirmed: Christine Gebski, Senior Process Applications Specialist, Applied Biosystems
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| 12.50 | Lunch
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| 14.00 | Multi-speaker panel session: downstream processing and chromatographic methods
Panellists:
Downstream processing and chromatographic methods
- Design, application and performance of technology platforms for generic recovery and purification
- Protease stability studies of different rProtein A constructs
- Characteristics of a novel, high productivity, cation exchange resin
- Process economy and productivity calculations
Dr. Laura Chirica, Product Manager BioProcess, GE Healthcare Life Sciences
Downstream process of influenza viruses
- Successful strategies for cell harvesting and product capture from high-density cultures
- Overcoming the large-scale process bottleneck imposed by chromatographic capture of product
- Design, application and performance of technology platforms for generic recovery and purification
- Computational and high-throughput approaches to efficient screening of chromatography and filter media
Dr Michael Wolff, Biotechnologist and Pharmacologist, Dynamics of Complex Technical Systems, Max-Planck–Institute |
| | Moderator: Avinoam Kadouri, Consultant, Manufacturing, Laboratoires Serono S.A.
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| 15.00 | Case study: high throughput purification process development - a scalable approach to rapid adsorbent selection and process optimisation
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Increasing pressure on downstream process development within the biopharmaceutical industry to achieve higher purities, shorter development times and more robust processes
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96-well plate methods to perform two key process development activities: identification of optimum purification media, and optimization of purification method
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Data showing selection of a preferred Mimetic Ligand affinity adsorbent for serum protein purification and method optimisation for CM, S, Q and DEAE ion exchange adsorbents
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Correlation with larger scale chromatography columns demonstrating the validity and usefulness of the high throughput multiwell plate concept |
| | Confirmed: Henry Charlton, Technical Support Manager, Prometic Biosciences
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| 15.30 | Afternoon tea
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| BIOPROCESS MONITORING AND CONTROL |
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| 16.15 | Utilizing digital technology to improve process scalability
- The role of OPC in the modern Life Science facility
- Tactical to Practical, the challenges and benefits of fieldbus communications
- How digital technology is converting OpX opportunities into PAT solutions
- Emerging digital technologies and their potential benefits
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| | Confirmed: Larry West, Executive Vice President of Sales, Finesse
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| 16.45 | Case study: challenges of improving the formulation and delivery of biopharmaceuticals
- Challenges to development of biopharmaceutical formulations that maintain physical, chemical and biological integrity
- Identifying issues of stability, degradation mechanisms, excipient effects and novel formulation strategies
- Identifying straight forward scaling concepts to ensure consistency of lab scale with manufacturing scale
- Ensuring consistency of equipment used in process development with technologies used in manufacturing scale-up
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| 17.00 | Chairman’s closing remarks and close of congress
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