| Day Two23rd June 2010 |
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| 08:40 |
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Chairman's introduction |
Dr. Fadel Hamed,
Associate Director, GT Operational Excellence,
Genentech
USA
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| 08:45 |
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Developing a Process Oriented Organisation - Dramatically Increasing Productivity
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Fully understanding underpinning processes and creating specific process oriented teams around them to drive productivity
- Developing work cells and cell based manufacturing around specific processes
- Creating process orientated teams and moving them dynamically in and out of processes
- Putting processes at the core of the organisations to gain competitive advantage
- Improving and innovating processes through a holistic process-oriented view
- Applying process thinking for better results.
- Defining a framework of a business process orientation and measuring the degree of business process orientation
Dr. Mark Proctor,
Director, Technical Service,
Medimmune UK Ltd.
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| 09:20 |
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Keynote: Green Production and Process Improvement - Realising the Opportunities for Cost Reduction |
Setting aggressive goals and achieving 15% reduction in greenhouse gas emissions whilst reducing water and and waste to landfill
- Reducing green house gas emissions by 15%
- Achieving 25% less water usage and 40% less waste to landfill
- Simplifying process steps on biosynthetic insulin by reducing solvent and urea use
- Tying process improvement to cost saving - discovering capital is less consumed by throughput needs
- Developing highly efficient processes and achieving financial returns
Steve Gillman,
Vice President, Global Health Safety and Environment,
Eli Lilly & Company
USA
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| 09:55 |
| Reducing Downstream Development Timelines |
Screening technologies for fast and customised process development
- Using minaturised and automated platforms - screening resins and conditions prior to upscaling to column chromatography
- Reducing material and labour costs during process development with new analytical technologies
- Adapting platform technologies to specific product needs
Philine Dobberthien,
Downstream Development,
Boehringer Ingelheim
Germany
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| Flexible Factory of the Future - Multi Product Manufacturing Strateties |
Creating flexibility within manufacturing operations - using lean develop parallel production systems · Successful capacity management and utlisation and cost forecasting
- Disposable factories - moving away from stainless steel
- Developing multi product parallel processes to deal with high titer productivity
- Creating successful platforms by optimising a mixture of plant design, innovation, lean management, regulatory affairs, analytical tool boxes and disposables
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- Understanding long product life cycles
- Creating strong platforms and robust processes to ensure transferability and scalability
Dr. Christian Grote-Westrick,
Director of recombinant protein production,
imusyn GmbH & Co. KG
Germany
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| Quality Management Across Multiple Manufacturing Sites |
Satisfying quality standards across multiple manufacturing sites - with the Genentech Product Quality Steward Programme
- Achieving high end level product quality
- Product quality stewards - a single point of contact with high level accountability
- Interfacing with QP
- Improving decision making
- Achieving real results and financial returns
Luis Cabassi-Latoni,
Senior Director Commercial Product Quality Support,
Genentech
USA
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| 10:35 |
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| 10:55 |
| Streamlining Purification Due to High Titers |
Next generation process improvements to modernise downstream processing
- Implementing next generation technologies to deal with higher titers
- Novel tools to streamline purification operations
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| Processing Next Generation Antibody Molecules |
Manufacturing ADCs - potent weapons for the oncology arsenal
- Creating a flexible facility to address toxicity or biological activity
- Developing flexible production strategies
- Conjugation strategies
- Ensuring containment
- Co-ordinating manufacturing logistics
- Understanding processes and overcoming challenges in antibody drug conjugate manufacturing
Dr. Tom Roher ,
Senior Director of ADC and Biochemical Technologies ,
Lonza
Switzerland
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| Appling 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 concept
- Securing that the business keep running with both current and new paradigm while implementing
- 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
Michael Schousboe,
Principal Scientist, Expert Manufacturing Science and Quality, Member of the ASTM E55 Committee on PAT,
Novo Nordisk
Denmark
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| 11:35 |
| Environmental Footprint Analysis - Single Use Systems vs. Stainless Steel |
Workshop: Identifying and managing product life cycle environmental impacts
- Calculating environmental sustainability of disposable technologies with a life cycle assessment (LCA)
- Better understanding environmental impacts of a single-use assembly throughout various stages - raw material extraction, manufacturing, logistics, use, and end-of-life
- Gaining valuable insights into the opportunities for developing more sustainable designs
- Addressing end-of-life management concerns
- Results, recommendations and preliminary findings from ongoing life cycle assessments of single-use technology vs. fixed-in-place stainless steel technology
Vikas Gupta ,
Group Product Manager Process Systems ,
Millipore Corporation
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| Total Containment Control |
Workshop: Mycoplasma Control in Cell Culture Media
- Mycoplasma risk considerations
- Key success factors for mycoplasma control using filters
- New developments helping to increase the mycoplasma safety
- How new developments can help to increase the overall economics
Stefan Egli ,
,
Pall Life Sciences
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| Online Measurements Workshop |
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Online measurements
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| 12:35 |
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Themed luncheon discussions |
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| 14:00 |
| Monoclonal Antibody Purification |
Expanding purification options for monoclonal antibodies
- A purification workflow that provides mAbs of high quality and purity
- Powerful polishing tool, ceramic hydroxyapatite media, and it’s ability to remove aggregates
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| opportunities in Alternative Expression Systems |
Fully understanding advantages and cost benefits of alternative expression vs. bacterial and CHO
- Reducing unnecessary capital investments with alternative expression systems
- Reducing long lead times to establish manufacturing operations
- Improving efficacy and potency of monoclonal antibodies by modifying glycosylation structures
- Using advanced genetic engineering to create a recombinant protein production system
- Meeting the demand for improved production techniques
- Facilitating the development of proteins whose complexity limit commercial viability in traditional production
Dr. John R. Gasdaska,
Senior Director, Protein Sciences,
Biolex, Inc.
USA
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| Faster Facility Start Ups |
Establishing Pfizer's first Irish biotech plant in record time
- Streamlining efficient commissioning, engineering, construction and quality standards
- Establishing CHO cell line processes
- Successful tech transfer strategies - interacting with R&D to ensure efficient transitions
- Developing effective people training programmes
- Manufacturing Temazemab for late stage phase III clinical trials
- Lessons learnt
Dr. Roni Dattani,
Pfizer,
Ireland
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| 14:35 |
| Downstream Processing 2.0: New Enabling Technologies for Protein Purification |
Workshop: Recent technology trends to overcome productivity crunches
- New cell separation methods
- Disposable chromatography
- Benchmarks in orthogonal virus and contaminant clearance
- Further integration of unit operations
Hélène Panier ,
Purification Technologies ,
Sartorius Stedim Biotech
Amélie Raveneau,
Purification Technologies,
Sartorius Stedim Biotech
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| Achieve Business Value Based on Knowledge and Continuous Improvement by Applying PAT |
- State-of-the-art and user-friendly software that is a result of the close collaboration between advanced research, industry and software development
- Deep and extensive understanding of biotech-specific applications of multivariate technology
- Transformation of expert material in statistics and mathematics into application-focused training courses
- Broad experience in consulting
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| DSM Workshop |
Villaume Kal,
Vice-President ,
DSM BioSolutions
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| 15:35 |
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Measuring Process Improvement Through Value Measurement Analysis |
Implementing measuring system analysis -effectively monitoring the value of projects and demonstrating financial improvement
Dr. Fadel Hamed,
Associate Director, GT Operational Excellence,
Genentech
USA
Mario Roman,
Operational Excellence Principal ,
Genentech
USA
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| 16:10 |
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Successful Opex - Creating Lasting Change
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Creating a successful paradigm shifts - changing a previous culture to an opex culture
- Gaining commitment from higher management and engaging the shop floor in tandem
- Enabling sites to sustain growth
- Heightening awareness of operational excellence
- Developing individuals
- Revisiting sites annually to bridge gaps and address challenges
- Creating new environments to foster change in order to leave old cultures behind
Edgar Sur,
Director of Operational Excellence, Product Supply Biotech/Product Supply NA,
Bayer Healthcare
USA
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| 16:50 |
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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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| 17:30 |
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Chairman's closing remarks and close of conference |
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