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Follow on Google News | Spotlight sessions at the upcoming Lyophilization USA ConferenceLyophilization is one of the most time consuming and expensive unit operations. There are many issues within lyopilization which need addressing, and improved drying technologies are needed for current and future products.
By: SMi Group Agenda highlights will include a spotlight on novel PAT and QbD principles, scale up and technology transfer, bulk lyophilization, and assessing phase separation in lyophilized protein formulation. Comparing and contrasting two methods of controlled nucleation for use in lyophilization: • Evaluation of two methods of controlled nucleation: pressurization / depressurization technology and "ice-fog" technology • Can controlled nucleation impart consistency whilst maintaining vaccine potency? • Impact on cycle time, consistency and moisture levels Morrisa Jones, Senior Scientist, Vaccine Drug Product Development, Merck & Co., Inc. Freeze dryer characterization and application to drug product development and scale up • Characterization of bench, pilot and industrial scale freeze dryers • Product characterization & measurement of Rp • Application of models to the development of a lyophilization cycle • Scale up • PAT applications to development and scale up Timothy McCoy, Associate Director, Pharmaceutical Development, Biologics Research and Development, Sanofi Challenges of lyophilized product development • Formulation challenges - Excipients selection - Dosage forms: solution, suspension, & oral melt - Route of administration: - Solvents: aqueous and non-aqueous - API: biologics & small molecules • Process challenges • Device selections Yanming Zu, Director, Research and Development, Abon Pharmaceuticals For media enquiries, contact Jinna Sidhu on +44 (0) 20 7827 0688 or hsidhu@smi-online.co.uk Conference: November 15 - 16, 2018 Workshops: November 14, 2018 Venue: Renaissance Woodbridge Hotel, New Jersey, USA Website: www.lyophilization- Follow us @SMIpharm Tag us #lyousa ---- ENDS ---- About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to- End
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