Boosting stability, delivery and longevity for pharmaceuticals and biotechnology

15th - 17th September 2009, BSG Conference Centre, London, UK

Background Info
Key Speakers

• Felix Franks, Director, BioUpdate Foundation
• Patrick Garidel, Head of Pharmaceutical Basic Development, Boehringer Ingelheim Pharma GmbH & Co. KG
• Kai Hasler, Manager, Contract Manufacturing and Process Transfer Business Development, Baxter Oncology
• Paul Matejtschuk, Principal Scientist, Standardisation Science, National Institute for Biological Standards and Control
• T.N. Thompson, President, Millrock Technology
• Kevin Ward, Director of Research and Development, BioPharma Technology
• Cor van Ingen, Senior Project Leader, Freeze-Drying and Product Stabilisation, Netherlands Vaccine Institute
• Maik Guttzeit, Team Leader, Validation, GEA Lyophil
• Pasqualino Loi, Professor of Biomedicine, University of Teramo
• Holger Groghanz, Assistant Professor, Department of Pharmaceutics and Analytical Chemistry, University of Copenhagen
• Stéphanie Passot, Head of Food Process Engineering and Microbiology, Inra AgroParisTech

Lyophilisation has become a crucial enabling process technology, without which close to 60% of biopharmaceuticals including enzymes, vaccines and monoclonal antibodies would not be available. With a greater trend to outsource manufacturing and an increasing number of biologic drugs requiring freeze-drying, this $1.5bn market is set to maintain its year-on-year double digit growth.

Although the commonest way to ensure longevity and stability for complex molecules, lyophilisation 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 science. 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 lyophilisation cycle will guarantee a safe and effective product.

Mastering these complex and inter-related requirements is no mean feat and Visiongain's 2nd Annual Lyophilisation conference provides distilled, market-focussed intelligence from development to production. With a workshop and sessions led by experts, you will gain a thorough understanding to provide the best outcome for your business, whether pharma or biotechnology. Case studies from industry will offer strategic insights to help you optimise key input and output parameters, and troubleshoot challenges from sterilisation and process optimisation, to dealing with temperature-sensitive molecules, viruses and cells. In addition you will also gain the latest insights into:
• The theory and practice of biomolecule stabilisation
• Selecting acceptable formulation components
• Designing buffers and measure buffer capacity
• Designing optimised freezing and primary and secondary drying protocols
• Improving analytical methodology to characterise frozen systems and freeze-dried solids
• Validating new container/closure systems
• Characterising the final dried formulation
• Accurately predicting product stability at the intended storage temperature
• Ensuring cGMP, QbD, QC and QA
• Consistently achieving the desired product quality
• Improving process dynamics and scale up

Who will be there?
Presidents, Chief Executive Officers, Senior VPs, VPs, Chief Scientific Officers, Directors, Business Development Managers, Professors, and Principal Scientists in:
• Research and development
• Freeze-drying process
• Process implementation and process engineering
• Compliance
• Protein/biochemical/vaccine/antibody engineering
• Sterile production
• Quality assurance and quality control
• Standardisation science
• Drug formulation
• Active pharmaceutical ingredients
• Pharmaceutical production
• Process development
• Manufacturing and engineering
• Licensing
• Product development
• Outsourcing/contract manufacturing
• Food/drug formulation
• Dried technology
• Packaging and labelling
• Gene therapy
• Microbiology
• Pilot plant operations