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Pre-congress briefing - 11 September 2007
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| ADDRESSING A PANDEMIC THROUGH RAPID SCALE-UP |
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| 08.00 | Registration and coffee
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| 09.00 | Chairman’s opening remarks
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| | Hans Huber, Technology Agent - Biopharmacetuical Production, Boehringer Ingelheim Austria
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| 09.20 | Key note address: vaccine production using mammalian cell lines
- What is the current research in non-egg cell-based vaccines?
- Cell-based methods of scaling-up vaccine production – using mammalian cells to grow a virus
- Is this the answer to rapid vaccine scale-up?
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| | Norbert Klein, Site Head Technical Operations, Novartis Vaccines and Diagnostics
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| 09.50 | The DNA vaccines market
- The potential of an Influenza DNA Vaccine
- Regulatory considerations
- Advantages of DNA vaccines over traditional vaccines
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| 10.20 | Morning coffee
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| 11.20 | Producing DNA vaccines using a novel non-fermentation technology
- Manufacturing DNA vaccines using a non-fermentation technology and potential for rapid scale-up
- A review of successes with DNA vaccines and their potential applications
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| | Yin Chen, Vice President, Research and Development, CytoGenix
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| 11.40 | Panel session: the future of DNA and non egg cell based vaccines
- What is the potential for scale-up compared to egg cell vaccines?
- How do DNA vaccines compare to non-egg cell vaccines?
- What key successes have been achieved with DNA vaccines?
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| | Moderator: Hans Huber, Technology Agent - Biopharmacetuical Production, Boehringer Ingelheim Austria Confirmed: Yin Chen, Vice President, Research and Development, CytoGenix Confirmed: Norbert Klein, Site Head Technical Operations, Novartis Vaccines and Diagnostics
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| 12.30 | Lunch
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| MANUFACTURING NEXT GENERATION THERAPIES |
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| 14.00 | Manufacturing antibody fragments
- What properties do antibody fragments have compared with traditional antibodies?
- What needs to be considered when selecting bioprocessing methods for antibody fragments?
- Industrial manufacturing of antibody fragments
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| | Leigh Bowering, Group Leader, Microbial Fermentation Research, UCB Celltech
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| 14.30 | Scale-up and manufacturing of scaffold molecules
- Scaffold molecules as an alternative to traditional antibodies
- Building a phage display library based on Kunitz domain protease inhibitors
- Scale-up and manufacturing considerations via yeast expression systems
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| | Andy Nixon, Senior Director, Discovery Research, Dyax
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| 15.00 | Afternoon tea
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| 15.45 | Demonstrating Comparability Following Scale-up: A Focus on Therapeutic Antibody Products
- European regulatory basis and considerations for a comparability exercise - Specifically the CMC data requirements following scale-up
- The rationale for the approach to ‘comparability’
- Case studies of ‘comparability’ at the CMC level
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| | Richard Turner, Director of Regulatory Affairs (UK, Era Consulting Group
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| 16.15 | Key considerations for manufacturing nanobodies
- Applications as fully-functional, single-domain antibodies
- How does nanobodies scale-up compare to traditional antibodies?
- Comparing nanobody activity with traditional therapies
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| 16.45 | Chairman’s closing remarks and close of pre-congress day
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Day one - 12 September 2007
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| POST TRANSLATIONAL MODIFICATIONS FOR BIOLOGICAL PRODUCTS |
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| 08.00 | Registration and coffee
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| 08.45 | Chairman’s opening remarks
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| 09.00 | Keynote address: a new microbial expression system for GMP manufacturing
- A system for expression of fusion proteins and peptides with autocatalytic cleaving properties
- Comparative studies for peptide manufacture
- Scaling-up according to GMP requirements
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| 09.30 | Alternative microbial expression system for recombinant protein production
- Alternative systems to E.coli and their advantages
- Production of recombinant glycoproteins in bacterial systems
- Identifying the most effective glycoforms
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| 10.00 | Glycosylation in plant expression systems
- The advantages of using a non-mammalian expression system
- The resulting challenges with glycosylation
- Clinical advance to phase III
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| 10.30 | Morning coffee
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| SCALE-UP FOR FERMENTATION AND CELL CULTURE |
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| 11.15 | Speed to patient / market as a key for success
- Overview of expression strategies for glycosylated biopharmaceuticals
- Benchmark: cycle time to MCB, productivity and yields
- Technological trends
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| 11.45 | Maximising scale-up effectiveness through media development technology
- Cell culture media development and cell culture engineering
- Enhancing the speed and accuracy of media development
- Optimising production cell lines for expression levels, growth and performance
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| 12.15 | Speed networking
This is the revolutionary, exciting, quick and non-pressured way to meet fellow conference delegates and industry peers in a 45 minute session. These brief meetings are the starting point for conversation and networking throughout the conference. This is where long-lasting and fruitful relationships begin. |
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| 13.00 | Lunch
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| 14.30 | What cells want - growth and optimising media from a cells perspective
- Media and supplements - the limitations of current approaches
- New science based approaches and recombinant, animal component free supplements
- Regulatory, manufacturing and productivity advantages
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| | Anthony Simula, Head of Research and Development, Novozymes GroPep Ltd
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| 15.00 | Panel session: achieving expression of biopharmaceuticals
- What are the key advantages and disadvantages of mammalian, microbial and plant expression systems?
- Achieving post translational modifications in your biopharmaceuticals
- Different strategies to enhance expression and increase speed to market
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| | Confirmed: Hans-Peter Knopf, Head, Protein Expression Technologies, Novartis Pharma
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| ADVANCING BIOPROCESSING |
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| 15.45 | Afternoon tea
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| 16.30 | Challenges and recent advances in industrial plasmid DNA manufacturing
- Novel host-vector system for production of resistance-free plasmids
- Maximizing plasmid yield by upstream optimisation
- Overcoming bottlenecks in large-scale downstream processing
- Addressing future needs and challenges
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| 17.00 | Beginning with the end in mind - the route to successful clinical and commercial production
- The importance of technology transfer
- Objective design and development considerations
- Optimisation, scale up and clinical manufacture - the critical paths
- Success factors
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| | Mark Rayner, Technology Transfer Manager, Eden Biodesign Ltd
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| 17.30 | Chairman’s closing remarks and close of day one followed by networking drinks reception
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| 17.40 | Networking drinks reception
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Day two - 13 September 2007
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| SAFETY AND QUALITY IN BIOPROCESSING |
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| 08.00 | Registration and coffee
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| 08.45 | Chairman’s opening remarks
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| 09.00 | Keynote address: the purification of antibodies in a high titre world
- Increasing fermentation titres
- Impact on existing facility design
- Downstream process solutions
- Increasing plant throughput
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| 09.30 | Improving product safety: pathogen reduction using purpose-designed affinity adsorbents
- The need for improved techniques for removal of viruses and prions
- Ligand library screening to identify and select compounds with binding affinity for specific pathogens
- Identifying ligands with a high affinity for prion proteins including Scrapie, BSE and vCJD
- Reducing the risk of prion transmission via biological products derived from human or animal sources
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| 10.00 | Evaluating the effect of changes in downstream processing on virus safety
- Regulatory requirements for VC studies in early and late clinical development
- Considerations for virus spike quality in virus clearance studies
- Robustness studies for virus inactivation and removal
- Column re-use and column cleaning studies
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| 10.30 | Morning coffee
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| ENABLING SCALE-UP IN DOWNSTREAM PROCESSING |
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| 11.45 | Influence of the binding mechanism on the development and optimisation of protein chromatography
- The difficulty of evaluating conditions for efficient protein separation by chromatography
- Reducing process development time via rational methods which predict chromatographic retention
- Using retention data to evaluate the binding mechanism and structure-retention relation
- Predicting and optimising protein separations
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| 12.15 | The role of ion-exchange chromatography in antibody production
- Monoclonal antibody purification schemes
- Screening tools for chromatographic resins
- Behavior of different ion exchangers
- Scalability and quality considerations for ion-exchange chromatography
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| 12.45 | Lunch
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| 14.15 | Development of an industrial capture step for a recombinant protein
- Development of an industrial capture step for a recombinant protein produced in a CHO cell culture system
- The limits of conventional chromatographic adsorbents for large scale purification of therapeutic proteins
- Development of two alternative technologies: chromatography on a custom affinity ligand-based adsorbent and aqueous two-phase partitioning systems
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| 14.45 | The limits of conventional chromatography
- The limits of batch operations
- The need to move from batch to continuous separation
- Increasing recovery and purity of your product
- New process based on continuous process multi-columns
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| STRATEGIES FOR AVOIDING PROCESS BOTTLENECKS |
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| 15.15 | Current limits of downstream processing and ways out of the dead end street
- Strategies for achieving high product yields
- Adapting downstream processing in response to high titres
- Can conventional methods meet the processing needs of the biopharmaceutical industry?
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| 15.45 | Afternoon tea
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| 16.30 | Panel session: latest advances in chromatographic methods to advance biomanufacturing
- Updates in design, application and performance of chromatography
- Best practice for facilitating recovery and purification
- How to predict conditions and binding mechanisms for optimised chromatography
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| | Moderator: Stephen Burton, Chief Executive Officer, ProMetic BioSciences Ltd Confirmed: Lothar Jacob, Marketing Manager Process Separations, Merck
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| 17.15 | How single-use technology can contribute by simplifying scale-up while reducing validation requirements
- Single use technology in downstream processing
- Applications using disposable technologies
- How this can improve scale-up and time to market
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| 17.45 | Chairman’s closing remarks and close of congress
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