9th Annual Biological Production Forum 2010

Dates: TBC

Venue: TBC

bio focus day | day one | day two

Biological Production 2009 Focus Day
24 June 2009
12:00 Registration
12:15 Luncheon sponsored by Atoll GmbH

Atoll


OPERATIONAL EXCELLENCE

CAPACITY MANAGEMENT
13:30
OPEX STRATEGIES
CAPACITY MANAGEMENT AND UTILISATION
 


Operational excellence - sustaining investment and demonstrating real improvements

  • Change is the most fundamental part of life and not all change is negative
  • How do you deal with change and how do you apply it to corporations?
  • Why do 78% of change programmes fail to create lasting change?
  • Implementing change execution analysis to understand how effective you are at initiating change
  • Changing style = change success profile - transforming business models and internal politics
  • Failure mode analysis – identifying the pattern of why

Dr. Fadel Hamed, Head of Operational Excellence, Genentech, USA


Managing external relationships for outsourced capacity and tech transfer projects

  • Successful CMO strategies - making crucial make or buy decisions
  • Defining core and non core technology, evaluating portfolios, understanding markets and risk processes
  • Innovative strategies for tech transfer and scale up –ensuring business excellence
  • Implementing project management expertise
  • Using the right financial models to guarantee ROI – net present values (NPV)
  • Continuous improvement and cost reduction in CMO’s


Dr. Ulrich Rümenapp, Contract Manufacturing Biotech, Head Biotech Projects, Bayer Schering Pharma AG, Germany

14:05
REDUCING COSTS AND IMPROVING EFFICIENCIES WORKSHOP
INTERACTIVE WORKSHOP
 
Interactive workshop: Stabilitech Ltd.: Vaccines and biopharmaceuticals: Reducing costs and improving efficiencies using an innovative technology

  • Eliminating the need for refrigeration and eradicating costly cold chains systems
  • Generating vaccines and other biological materials which are stable and effective in a dry state at different temperatures
  • Possibly achieving high concentration formulations
  • Improving solubility of currently insoluble proteins
  • Reducing antigen concentration and antigen sparing

Dr. Jeff Drew, Chief Scientific Officer and Founder, Stabilitech Ltd.,
Dr. Andre Habel, Businesses Development Executive, Stabilitech Ltd.,

Capacity planning and utilsation

Implementing lean management in capacity planning to realise optimal productivity in personal and logistical challenges

  • A new platform strategy in broad-range recombinant protein production: fermentation, harvest, quality controls
  • Planning and realising parallel production of more than one hundred recombinant proteins by several optimisation steps

  • Applying aspects of lean management and platform strategies - creating well-organised activities within production processes to achieve high productivities
  • Progressively increasing company portfolios
Dr. Christian Grote-Westrick, Director of recombinant protein production, imusyn GmbH & Co. KG, Germany
15:35 Networking and refreshments
16:00
BUSINESS EXCELLENCE STRATEGIES
BIO CAPACITY - MAXIMISING CELL CULTURE PRODUCTIVITY
  Implementing the Novartis innovation, quality and productivity initiative (IQP) - achieving real results
  • Transferring the success or the IQP initiative from pharma into biotech
  • Moving towards a three layer organisation and simplifying processes
  • Achieving real productivity gains and removing waste

Dr. Markus Schneider, Head, Centre of Biotechnology, Novartis Pharma , France

Achieving high productivities through cell culture selection, re-engineering and academic collaboration
  • Developing successful cell culture processes to achieve high antibody yields
  • Effectively selecting the most productive cell lines
  • Re-engineering cell lines to improve secretory pathways
  • Improving expression vectors for increased mRNA activity and secretory capacity
  • Collaborating with academia in cell culture development and process improvement
  • Successfully validating models to create commercially viable, industrial cell lines
Dr. Robert Young , Principal Scientist, Lonza Biologics plc, UK

 

16:35 Close of Bio Focus Day

bio focus day | day one | day two

Day One25th June
08:00
Delegate registration and refreshments
08:30
Chairman's introduction

Prof. Alois Jungbauer, Head, The Downstream Processing Group, Austrian Center of Biopharmaceutical Technology, BOKU Austria
08:35
IMPLEMENTING NEXT GENERATION MANUFACTURING PROCESSES
Achieving 75% lead time reduction and threefold productivity increases
  • Developing next generation manufacturing processes for old products
  • Using robust comparability studies and intense risk assessment
  • Aggressively using QBD on process mechanisms
  • Optimising extra capacity
  • Identifying potential bottlenecks

Kim Sandell, Director, Manufacturing, Pfizer Health AB Sweden
09:10
COST OF GOODS REDUCTION AND EFFICIENT PRODUCTION PROCESSES
New process development techniques and efficient production processes to guarantee COG reduction
  • Utilising solid economic procedures and processes - innovative strategies to reduce COG's
  • Using process efficiency analysis to increase production yields
  • Next generation manufacturing process development
  • Implementing statistical analysis and DOE principals

Alfred Luitjens, Senior scientist Upstream Development, Crucell The Netherlands
09:45
CONF ROOM 1: NEW IDEAS AND STRATEGIES IN CHROMATOGRAPHY AND BEYOND
Comparing the potency of chromatographic processes vs. new methods including precipitation and crystalisation
  • Chromatography modeling – finding an optimum way to set parameters
  • Developing advanced chromatographic techniques
  • Evaluating the relative merits of chromatographic processes vs. precipitation and crystalisation
  • Exploring the future potential of the new bio-separation techniques for biopharmaceuticals

Prof. Alois Jungbauer, Head, The Downstream Processing Group, Austrian Center of Biopharmaceutical Technology, BOKU Austria
 
CONF ROOM 2: NEW TECHNOLOGIES AS A KEY FOR INCREASED SPEED AND THROUGHPUT OF CHO CELL LINE DEVELOPMENT
Creating high yielding production cell lines ·
  • Optimising speed and yield of platform
  • Integrating internal and external know how
  • Reducing cycle time for cell line development
  • Developing high yielding fast processes

Dr.Zorica Dragic , Lab Head, Novartis Biologics Switzerland
 
10:20
Pre-scheduled one-to-one meetings
11:40
CONF ROOM 1: FLEXIBLE COST EFFECTIVE MAB PRODUCTION
Workshop

Monoclonal antibodies - tools to make high-dose biotherapeutics more affordable
  • Number of Mab projects sky-rocketing from 76 to 192 in just four years
  • Expensive facilities, capacity utilisation declining to 63%
  • Many Mabs at small scale require new levels of manufacturing flexibility

Dr. Günter Jagschies , Senior Director Strategic Customer Relations, GE Healthcare Life Science Sweden
 
CONF ROOM 2: PAT AND QbD IN BIOPHARMACEUTICAL MANUFACTURING
Workshop

PAT and QbD in biopharmaceutical fermentation process
  • Close the loop from real time monitoring to process adjustment
  • Elements and constraints of online analysis
  • Strategies of global data management

Andreas Schneider, Director global Sales, innovatis AG
 
CONF ROOM 3: UPSTREAM SINGLE USE SENSORS, SOFTWARE AND SYSTEMS
Workshop
Finesse

The Bermuda triangle of upstream single-use: sensors, software and systems
  • The singular focus of equipment providers on the bioreactor and bag
  • Crossing the chasm between the process and the bioreactor
  • Evolution: from PCs to industrial automation and back again

Dr Barbara Paldus, CEO, Finesse Solutions LLC USA
 
12:40
Networking luncheon
14:00
CREATING A FLEXIBLE AND ROBUST MANUFACTURING STRATEGY - CHALLENGES AND OPPORTUNITIES IN ANIMAL HEALTH
Learning from the challenges of animal health - transferring robust processes and maintaining competitiveness
  • Flexible manufacturing strategies - successfully running many products in one plant
  • Using manufacturing platforms to sustain innovation, remain competitive and capture market share
  • Achieving low costs of goods in animal health whilst ensuring quality and profitability
  • Meeting development timeline pressures
  • Achieving tech transfer and scale up success through process robustness
  • Overcoming regulatory challenges in disparate regulatory environments EMEA, USDA and JMAFF

Huw P. A. Hughes, Director Laboratory Sciences Biological Development, Pfizer Inc. USA
14:35
Pre-scheduled one-to-one meetings
16:20
NEXT GENERATION DOWNSTREAM PROCESSING PLATFORMS
Developing high yielding purification processes for an existing manufacturing network
  • Developing a purification process to recover twice the amount of product for which an existing plant was originally designed
  • Maintaining high yield and product quality, and transferability to multiple manufacturing sites
  • Addressing the challenges and trade-offs of a high yielding process on the purification operation of a marketed product
  • Truly understanding facility constraints, product characteristics and impurity profile
  • Achieving process approval

Dr. Benedicte Lebreton, Late Stage Purification, Process Development, Genentech USA
 
PROCESS TECHNOLOGIES FOR ANTIBODY PRODUCTION: ONE NOTCH UP
Advanced strategies for high throughput antibody production
  • Developing second generation process for higher titers and improved production economics
  • Accommodating high titers
  • Accommodating flexible processes with plug and play
  • CMO analysis - understanding equipment availability, evaluating resources and manufacturing capabilities

Dr. Alahari Arunakumari, Senior Director, Medarex USA
 
MANAGING PROCESS CHANGE AND ACHIEVING REGULATORY APPROVAL
Case study: Successful EU/EMEA examples of effective change control processes
  • Effective quality control strategies for globalised supply chains which require effective quality oversight
  • Practical examples of successful marketing authorisations
  • Understanding how to correctly describe processes using relevant detail skip
  • Managing process changes with a worldwide change control system
  • Determining level of change: a. validation impact, b. regulatory impact on the marketing authorisation
  • CAPA - reducing variability by taking corrective and preventative action for recurring problems and verifying batches are produced, tested and checked in line with the marketing authorisation and cGMP

Lex van Paassen, Manager Global External Manufacturing QA EMEA/Qualified Person, Global Pharmaceutical Supply Group GPSG , , Centocor B.V. The Netherlands
 
16:55
EFFECTIVE COG ANALYSIS PROGRAMMES
Support effective decision-making in the design and operation of antibody manufacturing process
  • Using an effective tool box for efficient COG analysis and understanding
  • Evaluate the cost effectiveness of alternative purification strategies
  • Using COG analysis for short, medium and long term production planning

Dr. Ying Gao, Research Associate, MedImmune Ltd UK
17:30
Chairman's closing remarks and drinks reception sponsored by Merck KGaA and featuring entertainment from The Drum Café
Merck


Prof. Alois Jungbauer, Head, The Downstream Processing Group, Austrian Center of Biopharmaceutical Technology, BOKU Austria

bio focus day | day one | day two

Day Two26th June
08:25
Registration and refreshments
08:55
Chairman's introduction

Prof. Alois Jungbauer, Head, The Downstream Processing Group, Austrian Center of Biopharmaceutical Technology, BOKU Austria
09:00
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
09:35
BIOTECH SUCCESS - BOOSTING COMPETITIVENESS AND PROFITABILITY
Panel debate: Please submit your questions prior to the event
  • 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
Dr. Fadel Hamed,
Head of Operational Excellence,
Genentech USA
Dr. Bill Haddad,
Chairman/CEO,
Biogenerics, Inc. USA
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
10:15
Morning refreshments
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
 
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
 
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
 
11:10
NEXT GENERATION DOWNSTREAM PROCESS DEVELOPMENT
Workshop
Millipore

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
 
ON DEMAND DATA ACCESS AND ANALYTICS
Workshop
Aegis

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
 
PRIMARY CELL REMOVAL WITH NOVEL DEPTH FILTER CAPSULES
Workshop: Primary cell removal with novel depth filter capsules
Pall Life Sciences

  • Filter design
  • Scale-up performance
  • Application details

Dr. Manfred Muehl, Business Development Manager, Pall Filtersystems GmbH Germany
 
12:10
Themed luncheon discussions
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
 
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
 
14:05
MONOCLONAL ANTIBODY PURIFICATION
Workshop:
BioRad

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
 
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
 
15:05