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4th Lyophilisation Workshop

Ensuring optimum formulations for pharmaceuticals and biologicals

7th - 9th September 2010, BSG Conference Centre, London, UK

Key Speakers

Filippo Orlandi,
Sterile Manufacturing Manager, GlaxoSmithKline
Otmane Bousif,
Head, Formulation Development – Biotech Products, Sanofi -Aventis
Richard Storey,
Associate Principal Scientist, AstraZeneca
Patrick Garidel,
Head of Pharmaceutical Basic Development, Boehringer Ingelheim Pharma GmbH & Co. KG
Joanne Broadhead,
Team Manager, Liquids Manufacturing, AstraZeneca
Miguel Galan,
Innovation & R&D Director, Telstar Lyo
Maik Guttzeit,
Team Leader, Validation, GEA Lyophil
Paul Matejtschuk,
Principal Scientist, Standardisation Science, National Institute for Biological Standards and Control
Kevin Ward,
Director of Research and Development, BioPharma Technology
Andrew Parker,
Associate Director, Molecular Profiles

Introduction
4th Lyophilisation Workshop

With over 130 products on the market worth $50bn, biologicals and biopharmaceuticals remain the
fastest growing segment amongst novel pharmaceutical entities today1, 2. Mirroring this trend, the
market for lyophilising these compounds, currently approaching 200 million units3, is set to continue its
year-on-year double digit growth.

Without lyophilisation, 60% of biotherapeutics including recombinant proteins, plasma, vaccines and
antibodies could not be commercially available3. Freeze-drying has become increasingly efficient in
recent years, easier to use, more cost-effective and extremely accurate. It imparts higher stability,
broader temperature tolerance, and longer shelf life to pharmaceutical formulations unstable in aqueous
solution4.

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Although the commonest way to ensure longevity and stability for complex molecules, lyophilisation
however remains costly, complex and facility-intensive. Fine-tuning cycle parameters and trial-and-error
experimentation also means the procedure remains as much of an art as a science5. As reducing
development time becomes increasingly important in today’s economic climate, a rational, empirical
approach to cycle design can save you time and money, especially when upscaling. More importantly, a
robust lyophilization cycle will guarantee a safe and effective product.

Mastering these complex and inter-related requirements is no mean feat and Visiongain’s 4th
Lyophilisation conference provides distilled intelligence on formulation and process development for
biopharmaceuticals. With a workshop and sessions led by experts, you will gain a thorough
understanding to provide the best outcome for your organisation. Case studies from industry will offer
strategic insights to help you optimise key input and output parameters, and troubleshoot challenges with
temperature-sensitive moieties or solid proteins.

Whether your interests lie in drug formulation, process engineering or strategic partnering, attending this
conference will enable you to:
• Develop rational approaches to pre-formulation processes for small molecule drugs and biologicals
• Exploit advanced scale-down and factorial DoE for formulation optimisation
• Design accurate product-specific freezing, sublimation and desiccation protocols
• Overcome low-temperature and drying-induced protein denaturation and aggregation
• Streamline analytical methodology to accurately predict and accelerate product stability
• Meet cGMP, QbD, QC and QA requirements and deliver consistent product quality
• Improve process engineering dynamics and scale up
• Troubleshoot manufacturing problems
• Implement PAT confidently and effectively in manufacturing and the laboratory
• Resolve challenges facing today’s industry
• Engage industry experts and cement new alliances

Who will be there?

Presidents, Chief Executive Officers, Vice Presidents, Chief Scientific Officers, Directors, Business
Development Managers, and Principal Scientists of:
• Vaccine/antibody/cell manufacturing
• Bioprocess research and development
• Chemical Engineering
• Process implementation and process engineering
• Stability testing
• Sterile production
• Quality assurance and quality control
• Standardisation science
• Drug formulation
• Active pharmaceutical ingredients
• Pharmaceutical production

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• Manufacturing and engineering

• Licensing
• Product development
• Outsourcing/contract manufacturing
• Dried technology
• Packaging and labelling
• Pilot plant operations

Workshop
Pre-conference Workshop,
Tuesday 7th September 2010

PAT for lyophilisation

The purpose of the workshop is to allow you to engage in knowledge sharing with your peers in a
smaller, less formal environment than the main conference. As such, the audience size will typically be
no more than 20 participants in order to enable maximum interaction between the workshop leader and
the delegates. The format is also more interactive, with less emphasis on ‘lecture-style’ presentations
and more emphasis on group discussions, exercises and Q&A sessions.

For more information visit

http://www.bharatbook.com/detail.asp?id=135237&rt=Conference-on-4th-Lyophilisation-2010-
Workshop.html

OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
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