| Day One22nd June 2010 |
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| 08:00 |
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Registration and morning refreshments |
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| 08:30 |
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| 08:35 |
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Future Capacity Utilisation |
Forecasting future capacity utilisation vis-à-vis new drug portfolios, MAB platform manufacturing strategies and downstream bottlenecks
- Forecasting future capacity utilisation Vis-à-vis new drug portfolios for hormone like and interferon products
- Understanding how monoclonal antibody platform manufacturing strategies will impact capacity utilisation
- Creating a mix of facilities for different needs – proteins vs. monoclonal antibodies
- Developing facilities for low tiers, high volume with normal and small volume bioreactors – creating a flexible manufacturing strategy
- Addressing capacity constraints for Downstream bottlenecks and addressing downstream variability
Dr. Wolfgang Berthold,
Chief Technology Officer,
Biogen Idec
Switzerland
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| 09:05 |
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Economic Cost of Goods Forecasting vis a vis Capacity Utilisation and Future Planning Requirements |
Using life cycle economics and cost analysis - evaluating lifecycle costs using single use systems, stainless steel within different manufacturing environments
- Cost comparisons in light of realistic projections for capacity utilisation and marketing forecasts
- Using true assumptions on future facility utilisation
- Calculating cost using correct boundary conditions
- Changing your strategies on reaching 50% capacity utilisation
- Understanding what future processes look like and how much will you need to produce
Dr. Markus Schneider.,
Technology Director,
Novartis Pharma
France
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| 09:35 |
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Shortening Development Timelines - Achieving Faster Transitions to Facilitate Commercial Scale Manufacturing |
Effectively managing the development timeline - creating a database in development and transferring it to manufacturing - accelerating development to platform technology
- Developing a database of knowledge during development to move away from three batch validation
- Building a knowledge database - demonstrating a continuum and understanding of multivariate analysis - what does this mean for release trajectory?
- How do you squeeze manufacturing execution systems harder to demonstrate ultimate statistical control
- Ensuring statistical control
- Balancing speed and risk whilst accelerating development plans
- Fast approval vs. robust processes. Shortening development of new products and cell lines. How do you schedule phase material ad how do you produce it?
Marc Bastiaansen,
Senior Staff Scientist,
Schering Plough
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| 10:05 |
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Pre-scheduled one to one meetings |
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| 11:25 |
| Improving Monoclonal Antibody Production by Host Cell Line Engineering |
Cell line engineering - achieving 8 grams per litre productivities
- Engineering platform technology to over express proteins
- Increasing cell capacity to excrete proteins
- Achieving extreme cell density
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Dr. Stefan Schlatter ,
Associate Director Cell Culture Technology,
Boehringer Ingelheim
Germany
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| Implementing QBD - Opportunities for Cost Reduction and Process Improvement |
Using QBD to as a competitive tool for process understanding, optimisation, continuous improvement and ultimate cost reduction
- Effectively managing change within the organisation
- Developing pilot projects to fully define and understand each relevant process step and then improving old process steps
- Utilising specific tools to make development more rational
- Exploiting process knowledge to reduce costs as part of a continuous improvement programme
- Successfully applying QBD to old and new processes and overcoming implementation challenges
- QBD - how do you get to a situation where you file your request to move to GMP manufacturing under QBD?
Dr. Alessandro Butte,
Director Downstream Processing,
Lonza
Switzerland
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| 12:05 |
| Process Efficiency by Innovative Measurement Solutions |
Workshop:
- How to reduce time in fast-track-projects with a main instrumentation vendor
- Expert’s support from Engineering through qualification to operation for increased process efficiency in the whole life cycle
- Sustainable concepts for innovative field instrumentation including PAT
- Compliant automation solutions: a case study
Klaus Köhler,
Industry Manager Life Sciences,
Endress+Hauser
Germany
Dr. Thomas Steckenreiter,
Marketing Director,
Endress+Hauser Conducta
Germany
Philipp Zumoberhaus,
Engineering Manager,
Endress+Hauser Process Solutions
Switzerland
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| Fully Disposable, Multiple Mab Processing for Clinical Trials |
Workshop
- Responding to the changes in scale of Mab processes
- Using a fully integrated ReadyToProcess platform for Mab manufacture.
- Challenges and opportunities presented when implementing a disposable manufacturing train
- Understanding when to follow an integrated disposable strategy compared to a traditional fixed facility
Dr. Gunter Jagschies,
Senior Director Strategic Customer Relations,
GE Healthcare Life Sciences
Sweden
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| Implementing a QbD Program To Make Process Validation A Lifestyle Rather than an Event |
Workshop:
- The relationship between process validation and QbD and why QbD starts in process development and doesn't end in manufacturing
- The business benefits and practical user requirements for QbD
- How to make paper-based data available for data analysis and the importance of data contextualisation and how to implement it
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- How to provide a self-service data access and analytics environment for QbD
- The benefits of using on-line and off-line data together for process analysis
- The value of removing technology and geographic barriers to collaboration
Dr. Justin Neway,
Executive Vice President and Chief Science Officer,
Aegis Analytical Corporation
USA
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| 13:05 |
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| 14:05 |
| Mechanistic Understanding of Virus Log Retention Value (LRV) Decline during Parvovirus Filtration |
Challenges associated with parvovirus filtration
- Methods to track virus transport during filtration
- Testing multiple mechanisms to understand decline in virus log retention value (LRV) with throughput
- Utilising the insights for designing next generation parvovirus filters
Dr. Amit Mehta,
Snr. Engineer/Group Leader Late Stage Purification,
Genentech
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| Applying QBD to Old and New Processes |
Implementing a global change management programme and rolling out the concept to the shop floor
- Discovering and developing QBD as a concept
- Securing that the business keeps running with both current and new paradigm during implementation
- Managing change in a global company – A harmonised approach to QBD
- Utilising examples from existing processes to prove the benefits of QBD - Improving quality, robustness, savings
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Michael Schousboe,
Principal Scientist, Expert Manufacturing Science and Quality, Member of the ASTM E55 Committee on PAT,
Novo Nordisk
Denmark
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| 14:40 |
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Pre-scheduled one-to-one meetings |
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| 16:25 |
| Third Generation Single-Use Bioreactor Systems: “Smart” Measurement and Control |
Workshop: Online measurements
- a. Single-use Sensors
- b. Modular Hardware
- c. Appealing interface
- d. Rapid validation
- e. Turnkey services
Dr. Barbara A. Paldus,
CEO,
Finesse Solutions, LLC
USA
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| Study of Ion-Exchange Media Surfaces Design for Efficient Purification |
- Robust and rapid processes
- Recovery of monoclonal antibodies and recombinant proteins
- Non-grafted versus grafted surfaces comparison of chromatographic media
Prof. Dr. Christian Frech,
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University of Applied Sciences
Germany
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| Single Use Bioractor Optimisation |
- System design concentrating on the mixing, sparging, monitoring and control options
- Modes of use and process operating parameters
- Data on scalability
- Case Studies
Jon Reid,
Director of Strategic Market Development,
Thermo Fisher Scientific
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| 17:25 |
| Developing Strategies for Answering Market Needs |
- Responding efficiently to emerging diseases
- Working to tight cost constraints
- Relying on core technologies
- Plastic vs Hard Pipe: when to choose one over the other
- Tech transfer strategies
Huw Hughes,
Head of Development,
Pfizer
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| World Class CMC Development Processes in Mammalian, Yeast and Bacteria Cell Products |
Optimising development processes to achieve flexibility and multi product production
- Developing highly productive generic platforms
- Using lean tools and value stream mapping
- Increasing product portfolios
- Developing robust processes - getting it right first time
Dr. Jesper Sonne Johansen,
Principal Scientist,
Novo Nordisk A/S
Denmark
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| 17:55 |
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Panel Debate Disposable Technology - Cost Comparisons and Flexible Manufacturing Strategies
Reducing huge investments with disposable technologies vs. stainless steel - understanding opportunities and risk
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- Should industry kill capacity in favour of disposables?
- What are the cost models for disposables?
- Lean manufacturing and CAPEX on disposables
- Using disposables for small scale vs. large scale processes
- Achieving flexibility with disposable technology
Dr. Alessandro Butte, Director Downstream Processing, Lonza, Switzerland
Dr. Christian Grote-Westrick, Director of Recombinant Protein Production, imusyn GmbH & Co. KG, Germany
Dr. Markus Schneider,Technology Director, Novartis Pharma, France
Dr. Jerry Kinzel, Eli Lilly USA
Dr. Frank Nagel, Head Development,
Centocor
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Huw Hughes,
Head of Development,
Pfizer
Dr. Uwe Gottschalk,
Group Vice President Purification ,
Sartorius Stedim
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| 18:25 |
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Chairman's closing remarks and drinks reception sponsored by Merck |
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