9th Annual Biological Production Forum 2010

21st - 23rd June 2010

Sheraton Frankfurt Hotel & Towers, Frankfurt, Germany

day one | day two

Day One22nd June 2010
08:00
Morning coffee
08:30
Chairman's intro

Dr. Fadel Hamed, Associate Director, GT Operational Excellence, Genentech USA
08:45
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
09:10
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
09:45
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?

Spencer Fisk, Senior Director Upstream Operations & Development, Schering Plough
10:15
Pre-scheduled one to one meetings
11:35
Downstream Purification Strategies for High Cell Densities and High Titers
Establishing new platforms to cope with extreme cell densities and vast productivity improvements
  • Evaluating and introducing new unit operations
  • New strategies in purificaton and chromatography
  • Cell culture conditioning
  • Using TFF -tangenital flow filtration as a strategy

Prof. Parviz A Shamlou, Senior Engineering Consultant, Eli Lilly and Co USA
 
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

Dr. Hitto Kaufmann, Director, Upstream Development, Boehringer Ingelheim Germany
 
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
 
12:15
Aegis Workshop
Workshop
 
Future Perspectives on Mab Manufacturing Workshop
Future perspectives on Mab manufacturing: effectively responding to changes in scale and integrating flexibility

  • 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, , GE Healthcare Sweden
 
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 instrumentationincluding 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
 
13:15
Networking luncheon
14:15
Improving The Interphase with Upstream by Continuous Processing
Developing a continuous process for upstream and downstream vs. compartmentalising processes
  • Reducing risk at interphase between upstream and downstream and improving product quality
  • Consolidating two business units - bringing upstream and downstream processing into one unit
  • Continuously monitoring unit operations to identify opportunities for process improvement
  • Using the most effective purification technologies according to product portfolios - crystalisation vs chromatography
  • Conditioning cell process to deal with high productivities

Dr. Indresh K. Srivastava , Associate Director , Novartis Vaccines and Diagnostics, USA
 
Reducing Production Timelines - Improving Facility Utilisation
Optimising production time in the bioreactor - model gains for reducing time and cost
  • Generating higher titers in 15-20 days and reducing this to 10-14 days
  • Achieving higher titers in reasonable production time
  • Achieving efficient facility utilisation

Dr. Bruno Figueroa, Senior Principal Scientist, Pfizer USA
 
Process Understanding and Manufacturing Intelligence - Enhancing Decision Making
Using PAT to achieve true process understanding - transforming data into process knowledge to improve future processes
  • Improving decision making across product lifecycles
  • Effectively stabilsing processes and reducing deviation
  • Demonstrating process understanding to regulatory authorities
  • Creating a collaborative environment with easily accessible data
  • Developing a database of knowledge during development to move away from three batch validation

Dr. Martin Warman, Scientific Fellow I Analytical Development, Vertex Pharmaceuticals USA
 
15:00
Pre-scheduled one-to-one meetings
16:30
Merck Workshop
 
CELLCA Workshop
An upstream technology and a philosophy devoted to manufacturability of biopharmaceuticals

Dr. Aziz Cayli, Chief Executive Officer, Cellca GmbH
 
Thermo Scientific Workshop
 
17:30
New Viral Clearance Initiatives
Evaluating new tools vs. standard viral clearance technologies and improving standard unit operations
  • Evaluating standard technology and improving unit operations with a variety of newer technologies
  • Realising the potential for Q membrane for viral clearance
  • Implementing new filters and nano filters to ensure high level viral clearance
  • Maximizing the viral clearance potential of mature technologies
  • Meeting the challenge of regulatory scrutiny on viral clearance initiatives

Judy K. Glynn, Senior Principal Scientist, Pfizer USA
 
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
 
Process Understanding and Opex
Using value stream mapping to identify and eradicate product loss and deviation
  • Developing a strategy to eliminate waste and improve product
  • Setting objectives to improve data integrity
  • Creating more robust processes
  • Eliminating product loss to free up capacity
  • Achieving increased flexibility in scheduling throughout operations

David Gardner, Head of Operational Excellence and IQP Global Technical Operations , Novartis Vaccines & Diagnostics
 
18:00
Panel Debate Disposable Technology - Cost Comparisons and Flexible Manufacturing Strategies

Reducing huge investments with disposable technologies vs. stainless steel - understanding opportunities and risk

  • 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

Huw Hughes, Head of Development, Pfizer
Dr. Uwe Gottschalk, Group Vice President Purification , Sartorius Stedim
18:35
Chairman's closing remarks and drinks reception

day one | day two

Day Two23rd June 2010
08:40
Chairman's introduction

Dr. Fadel Hamed, Associate Director, GT Operational Excellence, Genentech USA
08:45
Developing a Process Oriented Organisation - Dramatically Increasing Productivity
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.
09:20
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
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
 
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 ·
  • 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
 
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
 
10:35
Morning refreshments
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
 
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
 
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
 
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
 
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
 
Online Measurements Workshop
Online measurements

 
12:35
Themed luncheon discussions
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
 
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
 
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
 
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
 
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
 
DSM Workshop

Villaume Kal, Vice-President , DSM BioSolutions
 
15:35
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
16:10
Successful Opex - Creating Lasting Change
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
16:50
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
17:30
Chairman's closing remarks and close of conference

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