| Day Two26th June |
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| 08:25 |
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Registration and refreshments |
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| 08:55 |
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Chairman's introduction |
Prof. Alois Jungbauer,
Head, The Downstream Processing Group,
Austrian Center of Biopharmaceutical Technology, BOKU
Austria
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| 09:00 |
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GREEN MANUFACTURING STRATEGIES |
Results driven energy reduction programmes - continuous improvement in energy efficiency and cost reduction
- Understanding how to decouple business growth and CO2 emission
- Strategies to achieve 10% absolute reduction in CO2 whilst increasing throughput
- Lean production and continuous improvement - optimising production to maximise energy efficiency
- Creating energy efficient factories- intelligently re-thinking and optimising operations
- Moving away from carbon to renewable energy sources - re-investing energy savings into renewables
- Learning from the energy experts - partnering with energy companies and the WWF Climate Savers Programme
Jan Hoff,
Vice President Global Support,
Novo Nordisk
Denmark
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| 09:35 |
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BIOTECH SUCCESS - BOOSTING COMPETITIVENESS AND PROFITABILITY
Panel debate: Please submit your questions prior to the event
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- Next generation processes and strategies to boost competitive advantage and profitability
- Effective production economics and cost of goods reduction strategies
- Deploying an operational excellence programme -creating measurable results
- Harnessing the potential of biosimilars - opportunities and threats
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Dr. Fadel Hamed,
Head of Operational Excellence,
Genentech USA |
Dr. Bill Haddad,
Chairman/CEO,
Biogenerics, Inc. USA
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Dr. Li Hong Malmberg,
Associate Director Technical Operations,
Abbott USA |
Dr. Jeffrey Deetz,
Assistant Vice President Technology and Innovation,
Wyeth Biotech Development
USA |
Prof. Alois Jungbauer,
Head, The Downstream Processing Group, Austrian Center of Biopharmaceutical Technology,
BOKU Austria |
Dr Frank-Jan Nagel,
Head of Cell Culture Development,
Centocor The Netherlands |
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| 10:15 |
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| 10:35 |
| CONF ROOM 1: DOWNSTREAM PROCESS MODELLING AND SCALE UP |
Rapid development, scale-up, and validation of downstream purification processes with fewer resources
- Streamline process development by modeling and predicting chromatography separations
- Facilitate Scale up through process modeling of lab scale experiments
- Predict and prepare for unexpected scale up challenges with the use of Process models
Dr.Justin McCue ,
Senior Engineer,
Biogen Idec
USA
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| CONF ROOM 2: MASTERING BIOSIMLARS IN EUROPE AND CAPTURING FUTURE MARKETS |
Harnessing the power of biosimilars and improving profit margins
- Realising the potential for European biosimilars
- Creating significant new revenue streams and improving profit margins
- Mastering and replicating complex processes
- Reducing variability in the process
- Mitigating possible threats
- Utilising generics manufacturers for extra capacity
Dr. Bill Haddad,
Chairman/CEO,
Biogenerics, Inc.
USA
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| CONF ROOM 3: PRODUCT CHARACTERISATION |
Genotypic characterisation studies to prove stability of recombinant cell lines
- Cell line validation: risks and regulatory requirements
- GLP Testing protocols and innovative tools
- Testing strategy
- Practical issued faced and improvements in ten years experience
Dr. Emiliano Toso,
Molecular Biology Lab Head,
Merck Serono S.A.
Italy
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| 11:10 |
| NEXT GENERATION DOWNSTREAM PROCESS DEVELOPMENT |
| Workshop
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Implementing disposable process platforms to reduce product development costs and increase flexibility
- Reviewing the key challenges of process developers in downstream purification
- Comparing the design, validation and operating costs of stainless steel vs. disposable systems
- Case studies on understanding how new integrated disposable platforms can make process development more effective
Gerd Walter ,
European Technology Manager Downstream bioprocessing ,
Millipore
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| ON DEMAND DATA ACCESS AND ANALYTICS |
| Workshop |
Achieving the goals of QbD and PAT – bridging the gap between process development and manufacturing
- Quality by design (QbD) starts in process development
- Business benefits and user requirements for QbD
- Tools for achieving QbD in pharmaceutical processes - on-demand data access for QbD collaboration
- Electronic and paper-based data
- Using on-line and off-line data together for analysis
- A multi-disciplinary collaborative analytics environment - leveling geographic and departmental barriers
Dr. Justin O Neway,
Chief Science Officer,
Aegis Analytical Corporation
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| PRIMARY CELL REMOVAL WITH NOVEL DEPTH FILTER CAPSULES |
Workshop: Primary cell removal with novel depth filter capsules
- Filter design
- Scale-up performance
- Application details
Dr. Manfred Muehl,
Business Development Manager,
Pall Filtersystems GmbH
Germany
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| 12:10 |
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Themed luncheon discussions |
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| 13:30 |
| CONF ROOM 1: HIGHLY PRODUCTIVE DOWNSTREAM PROCESSES |
Implementing a QbD focused, highly productive process that successfully translates into manufacturing operations
- Evaluating strategies for high productivity processes and understanding how they translate into manufacturing
- Simple and elegant design - creating opportunities in the facility and overcoming regulatory challenges
- Converting an old plant vs. building a new greenfield site
- Understanding how to create streamlined process according to facility size and complexity
- Achieving QBD, understanding capacity constraints and implementing new technologies
- Green processes - where do we need to go? Combining stainless steel and disposables , reducing foot prints, water and buffers
Dr. Jeffrey Deetz,
Assistant Vice President Technology and Innovation,
Wyeth Biotech Development
USA
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| CONF ROOM 2: ACHIEVING PROCESS ROBUSTNESS THROUGH PAT IMPLEMENTATION |
Controlling processes and reducing variability to achieve robust upstream systems
- Using PAT to gain a better understanding of cell culture systems and titer challenges
- Successfully implementing automation in cell culture systems
- Reducing and controlling variability to achieve robust upstream processes
- Evaluating results
Dr. Li Hong Malmberg,
Associate Director Technical Operations,
Abbott
USA
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| 14:05 |
| MONOCLONAL ANTIBODY PURIFICATION |
| Workshop: |
Expand your purification options for monoclonal antibodies
- A purification workflow that provides mAbs of high quality and purity
- Presentation of data from several monoclonal antibody purifications
- Discussion of a powerful polishing tool, ceramic hydroxyapatite media, and it’s ability to remove aggregates
Paul Ng,
Process Applications R&D, Life Science Group,
Bio-Rad Laboratories
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| CELL CULTURE MEDIA OPTIMISATION STRATEGIES |
Workshop: Satisfying high performance targets for media and supplements
- Qualification criteria for cell culture media and process supplements
- Reducing material variability
- Satisfying media and supplement qualification and application targets
- Material characterisation technologies
- Relationships between process inputs and performance through identification of critical raw material attributes
- Single-use bioreactor optimisation
Jon Reid,
EU Bioprocess Market Manager,
Thermo Scientific
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| 15:05 |
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