3RD – 5TH SEPTEMBER 2008, BSG CONFERENCE CENTRE, LONDON, UK

Harnessing the freeze-drying process for product delivery to reduce overheads and increase profits
"The market for lyophilised biologicals is expected to reach 150 million units by 2010”

Genetic Engineering & Biotechnology News

Over the last few years, lyophilisation has become a crucial enabling process technology for many important drugs. It has meant that material can be easily stored, shipped and later reconstituted to its original form for injection, and this has brought many new applications and the possibility for reducing costs. If you have not yet taken steps in this direction, or you’d like to know how to improve your portfolio, our lineup of expert speakers at the 2008 Lyophilisation conference will be on hand to share their knowledge and experience. This one-off event promises to bring together leaders in the fi eld, so why not take the time to reserve your place? However, freeze-drying is also a complex, costly, and facility-intensive process that many companies do, but only a few do well. By attending this conference, you will fi nd out what steps need to be taken in order to stay competitive, and also to keep on the right side of the regulators. And with the fi eld of drug discovery now experiencing impressive advancements through maturing technologies, those at the forefront will lead the way in this profi table sector. Reserving a place at this conference will provide a practical approach to help you develop strategies for successful formulation, lyo cycle development and optimisation, validation, and scale-up.Visiongain’s hotly-anticipated event will enable you to examine the latest technological breakthroughs, discuss and debate scientifi c processes, share the expert’s opinions on all aspects of lyophilisation, and forge the right partnerships for the coming years. Places are limited, so I invite you to book now to avoid missing out on what promises to be a unique exchange of knowledge and ideas.

I hope to see you there.

Best regards,

Who should attend?

• Head of Drug Development Strategy
• Director of Drug Safety/Risk Management
• Head of Project Packaging
• VP/Head of Research & Development and Product Safety/Stability Assessment
• VP/Head of Patient Safety and Outcomes Research and Data Analysis
• VP/Head of Regulatory Affairs and Compliance
• VP of Sales & Marketing

Sponsorship and exhibition opportunities:

This event offers a unique opportunity to meet and do business with some of the key players in the pharmaceutical and biotech industries. If you have a service or product to promote, you can do so at this event by:

• Hosting a networking drinks reception
• Taking an exhibition space at the conference
• Advertising in the delegate documentation pack
• Providing branded bags, pens, gifts, etc.

If you would like more information on the range of sponsorship or exhibition possibilities for Lyophilisation for Pharmaceuticals 2008 Conference, please contact:

• Identifying defects in products
• How to improve reliability and reproducibility

• Visually assess a series of lyophilised products whose different freeze-drying characteristics mean that they have dried to exhibit a range of structural patterns
• Evaluating the critical temperature
• Analysing the propensity of a formulation to form a surface skin on Scale-up of the freeze-drying process
• From small to large
• Pre-empting problems encountered

• Identifing the issues that are likely to contribute to product defects
• What steps might be taken to resolve the problem?
• How to produce a URS document

Day 1 LYOPHILISATION FOR PHARMACEUTICALS 2008

THURSDAY 4TH SEPTEMBER 2008

Dr Narlin B Beaty
Managing Partner

• Structural characterisation of freeze-dried solids
• Understanding formulation development and critical factors in the stability
of freeze-dried solids
• Overcoming the challenges with drying of vaccines
• Analysing freeze drying of scaffolds for tissue engineering
• Freeze drying of lipoplexes and virus-like particles

Director, Translational Research

• Understanding protein stability and process variations
• The chemistry of protein and peptide degradations in amorphous solids
• Structure and dynamics in the amorphous solid state
• Application of thermal analytical methods to accelerate lyophilisation
cycle development
• Case study: Freeze-drying cycle development for Kogenate-FS

Dr Lavinia Lewis
Research Scientist

• Process development and scale-up
• Principles of lyophilisation cycle scale-up
• Optimisation and scale-up of a lyo cycle for a popular product
• CRO and enterprise requirements

Senior Director, Pharmaceutical Research and Development Editor-in-Chief

Jόrgen Grebe
Head of Marketing & Sales
Martin Christ GmbH

• Advances in laser doppler shift spectroscopy to determine real-time in-process mass flow rate reactions
• Advanced uses of freeze-drying microscopy for product and lyo-cycle development
• Evaluation of manometric temperature measurement
• Moving beyond current limitations

Patrick Carl
Head of Capacity Management Technical Operations
Merck

• What can be done and to what extent can it be successful?
• How to make sure you carry out the preparation process correctly?
• How to reduce the degradation process?
• Discussion of recent results

Department of Systems Research

• Avoiding activation of a plasma sample during the lyophilisation process
• Performance and interpretation of various neurologic examinations
• What is the impact on the future?

16:00 Towards successful lyophilisation: The refinement of formulation against process cycle physical chemistry of the amorphous solid state
• Improving efficiency of cycle management and closure
• Introduction to spray freeze drying
• Spray-freeze-drying in the manufacture of pharmaceuticals
• Pair-wise distribution functions and structure in glasses

16:40 Influence of the physical state of an amorphous solid on its dynamics
• Predicting stability in freeze dried solids: Acidity in the solid state and other factors
• Do prospective studies always require prolonged periods of follow up?
• Exploiting conventional weaknesses

Dr Narlin B Beaty
Managing Partner
Qualification Process Solutions

• Mixing properties of lyophilised protein systems, calorimetric and spectroscopic studies
• Monitoring the impact of action taken
• Best practices and lessons learned

Lydia Dolezel
Auditor - Computer Systems Quality

10:20 The influence of crucible material on the thermal properties of a collagen solution
• Increasing volumes, improving outcomes, and boosting revenue
• Overcoming increased competition and rapidly changing frameworks
• Comparison to freeze-drying microscopy results

11:20 Utilising near infrared spectroscopy in the formulation development
• Qualitative analysis of raw materials
• Investigation of special properties
• Moisture determination

R&D Mφlndal Development of Lyophilized Formulations

12:00 Practical considerations of scale-up and technology transfer of lyophilised products
• Equipment considerations
• Product characterization and scale-up concerns
• Process understanding and the impact of scale-up on the lyophilization cycle
• Technology transfer of lyophilized processes

Senior Scientist

• Selection criteria and technologies to meet the increasing requirements for lyophilisation stoppers
• Machinability, protection against volatiles and leachables from the closure
• Protecting the drug against moisture and oxygen permeation
• Summary of improvements made to rubber formulas and coating technologies
• Case studies: Evaluating residual moisture and permeation of moisture through the stopper and their effect on moisture content, as a function of rubber material, sterilisation cycle and drying procedure

Director, Scientifi c & Technical Customer Services Europe/Asia Pacifi c

• PAT in the laboratory case studies: testing the smart freeze dryer
• A PAT approach to in-line control of the lyophilisation process
• 100% leak detection of lyophilisate vials by non-destructive laser absorption technology
• Applying PAT to the lyophilisation process: What must be done in order to achieve real time release?
• PAT implementation in lyophilisation and PAT-support for successful upscale

Associate Director Manufacturing Technology

• Complex products and technologies
• Root cause analysis and risk assessment for lyophilised Products
• Leak detection and head space gas analysis, inspection solutions for
lyophilised products
• Current case studies

16:10 Innovative software and devices to monitor the primary drying phase of freeze-drying processes
• How can enterprises integrate with business processes and applications?
• Pharmaceutical target validation
• Matrix validation approaches for lyophilised products
• Zero loss strategy - measures taken for freeze-dryers in biopharmaceutical products
• Microwave and continuous freeze dryers
The panel will be joined by key speakers from both days