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Congress day one 17 September 2008
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08.00 | Registration and coffee
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09.00 | Chairman’s opening remarks
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| | Dr Avinoam Kadouri, Scientific Advisory Board, Sigma Aldrich and SAFC Biosciences, and Chief Executive Officer, Rainbow Biotechnologies
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| SCALE-UP FOR FERMENTATION AND CELL CULTURE |
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09.10 | Keynote address: speed to patient / market as a key for success
- Overview of expression strategies for biopharmaceuticals
- Benchmark: cycle time to MCB, productivity and yields
- Technological trends allowing for fast tracked bioprocessing
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09.40 | Panel session: squeezing more from Mammalian cells: integration strategies for improving 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
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| | Moderator: Dr Avinoam Kadouri, Scientific Advisory Board, Sigma Aldrich and SAFC Biosciences, and Chief Executive Officer, Rainbow Biotechnologies
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10.20 | Speed networking
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11.20 | Morning coffee
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11.50 | Case study: novel, advantaged and safe protein biopharmaceutical production platform based on a highly developed strain of Pseudomonas Fluorescens
- An extensive library of host strains and expression strategies have been established
- Protein secretion and disulfide bond formation are particularly advantaged
- Advantaged downstream processing utilising periplasmic release
- Pfenex Expression Technology™ is the most comprehensive production platform available in the industry today
- Case studies will be shared that exhibit the advantages of using Pfenex Expression Technology™
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12.20 | Case study: select CHO: the development of a High
Performance CHO medium using design of experimentsfor base medium and hydrolysate optimisation
- A new high performance CHO medium
- Developed through rationale design using DOE
- Optimised base medium coupled with optmised supplementation strategy
- Significant enhancement of performance over a range of CHO cell types
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12.50 | Lunch
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14.00 | Boosting output in large scale manufacturing by cycle time optimization
- Cost drivers of a biotech facility
- Cycle time reduction by parallel processing
- Multipurpose facilities in order to maximize output
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14.30 | Panel session: boosting use of microbial systems in biomanufacturing
- Fundamentals of microbial growth, growth kinetics, strain development, and scale-up strategies
- Scale-up strategies and media formulation in fermentation processes
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| | Confirmed: Dr Bo Kara, Head of Expression and Cell Sciences, Avecia
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15.10 | Panel session: overcoming challenges in biopharmaceutical scale-up to production
- Outstanding challenge of cell line development, media formulation, fed-batch process definition and scale-up
- Enabling tools and technologies, novel approaches and practices for speedy and efficient process development, optimisation and scale-up
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| | Confirmed: Dr Ralph Kempken, Head of Pilot Fermentation / Upstream Development, Boehringer-Ingelheim Confirmed: Dr James Brooks, Research and Development Manager, BD Biosciences
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15.50 | Afternoon tea
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16.10 | Case study: production of optimised biopharmaceuticals in glyco-engineered mosses
- The advantages of using a non-mammalian expression system
- The resulting challenges with glycosylation and glycol-engineered mosses
- Clinical advances to date and forward looking practice
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| Advanced economical single-use bioprocessing |
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16.40 | Case study: Bioengineering advances through fermentor and bioreactor design and scale-up
- Fermentor and bioreactor design criteria to maximise efficiency
- Integrating large scale fermentors and bioreactor facility design
- Design concerns with large scale fermentors and bioreactors
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17.10 | Case study: Cell culture technology for pharmaceutical and cell based therapies
- Overcoming key challenges during implementation efforts
- Evaluating the future of disposable technologies
- Understanding the cGMP and regulatory perspectives
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17.40 | Close of congress day one followed by networking drinks
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Congress day two 18 September 2008
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08.00 | Registration and coffee
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09.00 | Chairman’s opening remarks
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| ECONOMICAL RECOVERY AND DOWNSTREAM PROCCESSING |
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09.10 | Case study: a "non-standard" approach to scale-up of chromatography
- Current trends with the potential to tackle the backlog in bioseparation technologies: highlighting chromatographic and membrane separation technologies
- Integration of upstream and downstream processes and the evelopment of new separation technologies
- Biotherapeutics adding further complexity and requiring alternative approaches to separation technology
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09.35 | Case study: scale-up of bioprocessing systems for purification
- Column scale-up with compressible media and the role of wall effects
- Scale-up of buffer from small to intermediate scale
- Packing consistency and efficiency achieved through automated packing
- Innovative, process solutions enabling scale-up in downstream processing
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10.00 | Case study: scouting for optimised protein purification
with the protein-purification-parameter-screening system
- PPPS system allowing efficient purification of proteins
- Protein purification protocols developing a purification scheme to monitor increase in yields and specific activity
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| | Dr Hartmut Schlüter, Head of Bioanalytical Laboratory of Nephrology, Charité University Medicine Berlin
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10.25 | Panel session: bioprocessing system scale-up for protein
purification
- Developing tools and techniques for the rapid, cost effective design and development of new selective capture technologies for purification of new products
- Basics of validation and how they impact process design
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| | Confirmed: Dr Frans Hoeks, Director of Product Management, F. Hoffmann La Roche
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11.05 | Morning coffee
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11.35 | Case study: impact of surface modification on the retention
of proteins in ion exchange chromatography
- The difficulty of evaluating conditions for efficient protein separation by chromatography
- Reducing process development time via rational methodswhich predict chromatographic retention
- Predicting and optimising protein separations
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| | Dr Christian Frech, Director of the Steinbeis Transfer Centre for Technical Advice, University of Mannheim
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| THERAPEUTIC SAMPLE PROCESSING |
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12.00 | Case study: process for the purification of FC-fusion proteins
- Protein purification suggesting promising new approaches
- The suitability of current techniques to purify plasmid proteins
- Review of the benefits and limitations of current plasmid purification and scaleable, robust downstream processes
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12.30 | Case study: fast-track process development for industrial
plasmid DNA production
- Setting standards for industrial plasmid DNA manufacturing
- Generic platforms applicable for any product
- Measures to reduce development time and costs
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| | Dr Hans Huber, Technology Agent, Biopharmaceutical Production, Boehringer Ingelheim
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13.00 | Case study: design and scale-up of downstream processing
of Monoclonal antibodies (mAbs)
- Selecting analytical methods to quantify bioproducts in bioseparation processes
- Basic science of each bioseparation unit operation leading to correct decisions during bioseparations process troubleshooting and design
- Interpreting data taken from operation of bioseparations equipment
- Successful scaling-up bioseparation processes
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| | Dr Andreas Stein, Head, Laboratory for Biochromatography Research, Performance & Life Science Chemicals Division, Merck KGaA
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13.30 | Lunch
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14.30 | Case study: establishing a benchmark for economic vaccine
scale-up strategies
- How can organisations prepare for sufficient vaccine production capacity during uneven levels of demand?
- What novel approaches can be used to speed up vaccine production to address a shortfall in supply?
- How are novel technologies aiding the scale-up inproduction of vaccines?
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| | Dr Simon Hsu, Associate Director, Purification Development, MedImmune Vaccines
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15.00 | Case study: future growth of whole cell bioprocessing for
regenerative medicine therapies
- Growing cells in conditions that maintain cell functionality to preserve therapeutic effects
- Potential development opportunities
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| | Dr Craig Stewart, Chief Technical Officer and Vice President, Progenitor Cell Therapy
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15.30 | Afternoon tea
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16.00 | Panel session: overcoming challenges in therapeutic
sample processing
- Manufacturing steps: isolation, culture, expansion, manufacture and clinical delivery
- What challenges have the greatest impact on sample processing and how to overcome them
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| | Confirmed: Dr Hans Huber, Technology Agent, Biopharmaceutical Production, Boehringer Ingelheim Confirmed: Dr Andreas Stein, Head, Laboratory for Biochromatography Research, Performance & Life Science Chemicals Division, Merck KGaA Confirmed: Dr Simon Hsu, Associate Director, Purification Development, MedImmune Vaccines
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| STREAMLINING BIOPROCESS DESIGN |
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16.30 | Case study: implementation of Quality by Design during
media and process development for fed-batch processes
- Strategies to improve product yield and in turn cost
- Process design and process monitoring and control
- Building validatability and scalability into bioprocessing
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17.00 | Close of congress day two
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Post-day briefing - 19 September 2008
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08.00 | Registration and coffee
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09.00 | Chairman’s opening remarks
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| MANAGEMENT STRATEGY AND OPERATIONAL EFFICIENCY |
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09.10 | Opening address: the coming of age of biopharmaceutical
manufacturing
- Current trends, impacts and strategic role of biopharmaceutical operations
- Where is manufacturing going over the next ten years?
- What are the latest developments within this field?
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09.40 | Keynote address: biopharmaceutical manufacturing trends:
long term viable manufacturing solutions
- Manufacturing biologics: the perspective from a biopharmaceutical manufacturer
- Strategic importance of manufacturing in product development
- Case studies on successful approaches to manufacture
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10.10 | Keynote address: a paradigm shift in cell culture based
biomanufacturing processes
- Historical overview of successful biomanufacturing in cell culture technology and state of the art biomanufacturing technology
- The paradigm shift in design, multi-use facilities and making use of efficient and flexible biotech plants
- Underlining the global manufacturing challenges that we all face
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10.40 | Panel session: predicting innovation in biomanufacturing
- Where do the main bottlenecks and challenges remain within biomanufacturing?
- What novel approaches can be applied to address current shortcomings?
- How can the major stakeholders of pharma, biotech and CMOs interact?
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| | Confirmed: Professor Rolf Werner, Managing Director, Corporate Division, Biopharmaceuticals,, Boehringer Ingelheim Confirmed: Dr Wolfgang Noe, Vice President, Bioprocess Development, Biogen Idec Confirmed: Dr Ernst Hetzl, Director, Global Manufacturing Technology, Baxter Bioscience
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11.10 | Morning coffee
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| ECONOMIC MANUFACTURING STRATEGIES |
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11.40 | Use of operational excellence as a strategic weapon to
optimise biopharma production
- The future of fermentation/purification/packaging networks
- Creating the ideal manufacturing facility
- Investing in or divesting capacity to meet longer term demand
- What strategies are being implemented to improve manufacturing across the industry? Building for the future
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12.10 | Secure future growth with continuous improvement and capacity investments: today’s lost sales can’t be
recovered tomorrow!
- Is there any need for building more capacity?
- Capacity is a rigid upper constraint which limits strategy and sales!
- How does the option to capture upside demand impact capacity value?
- Ability to capture demand upside increases potential operating income significantly
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| | Dr Patrick Carl, Head of Capacity Management Technical Operations, Merck Serono
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12.40 | Panel session: strategic and economic challenges of
increasing biopharmaceutical supply
- Experience with biomanufacturer management
- Fast track process development to support cGMP manufacturing of a complex fusion protein for pivotal clinical trials
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| | Confirmed: Dr Wolfgang Noe, Vice President, Bioprocess Development, Biogen Idec Confirmed: Mr Patrick Carl, Head of Capacity Management Technical Operations, Merck Serono
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13.10 | Lunch
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| COST MODELING FOR ECONOMIC MANUFACTURE |
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14.10 | Developing a framework of cost of goods and cost modelling
- Benefits and applications of cost modelling for biological bioprocessing
- Preparing cost-models for new biopharmaceutical projects, outsourcing initiatives and proposed technologies
- A framework for a Cost of Goods (COG) model
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| TECHNOLOGY TRANSFER FOR OUTSOURCING |
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14.40 | Technology transfer to ensure an effective
biomanufacturing process
- Critical factors and timelines for a successful technology transfer
- Transfer process know-how into efficiency improvements during design and construction
- Transfer know-how, efficiency improvements and GMP requirements into regulatory strategy to gain approval
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| | Dr Bo Kara, Head of Expression and Cell Sciences, Avecia
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15.10 | Afternoon tea
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15.40 | Case study: technology evaluation and process development
strategy for the production of biopharmaceuticals
- Technology transfer to ensure an effective manufacturing process
- Critical factors and timelines for a successful technology transfer
- Technical and regulatory requirements for upscaling to different scales at multipurpose facilities
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16.10 | Pharmaceutical outsourcing strategies promoting
economic manufacture
- Pharmaceutical outsourcing strategies promoting economic manufacture
- Emerging fields in the pharmaceutical outsourcing market for biological products. Why outsource manufacturing and risk costly technology transfer delays?
- Analysing best practice outsourcing strategies to ensure implementation into future processes
- Critical assessment of biomanufacturing outsourcing focusing on key current issues such as patent protection and related legislative changes
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| | Dr Annie Van, Director of Biologics Operations, Innogenetics
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16.40 | Close of biomanufacturing strategy briefing day
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