|Event Date/Time: Sep 07, 2010||End Date/Time: Sep 09, 2010|
|Registration Date: Sep 07, 2010|
|Early Registration Date: Sep 07, 2010|
4th Lyophilisation Conference
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.
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 todayâ€™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 Visiongainâ€™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:
â€¢ Develop rational approaches to pre-formulation processes for small molecule drugs and biologicals
â€¢ Exploit advanced scale-down and factorial DoE for formulation optimisation
â€¢ Design accurate product-specific freezing, sublimation and desiccation protocols
â€¢ Overcome low-temperature and drying-induced protein denaturation and aggregation
â€¢ Streamline analytical methodology to accurately predict and accelerate product stability
â€¢ Meet cGMP, QbD, QC and QA requirements and deliver consistent product quality
â€¢ Improve process engineering dynamics and scale up
â€¢ Troubleshoot manufacturing problems
â€¢ Implement PAT confidently and effectively in manufacturing and the laboratory
â€¢ Resolve challenges facing todayâ€™s industry
â€¢ 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:
â€¢ Vaccine/antibody/cell manufacturing
â€¢ Bioprocess research and development
â€¢ Chemical Engineering
â€¢ Process implementation and process engineering
â€¢ Stability testing
â€¢ Sterile production
â€¢ Quality assurance and quality control
â€¢ Standardisation science
â€¢ Drug formulation
â€¢ Active pharmaceutical ingredients
â€¢ Pharmaceutical production
â€¢ Manufacturing and engineering
â€¢ Product development
â€¢ Outsourcing/contract manufacturing
â€¢ Dried technology
â€¢ Packaging and labelling
â€¢ Pilot plant operations
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 â€˜lecture-styleâ€™ presentations and more emphasis on group discussions, exercises and Q&A sessions.