Fourth Annual Lyophilization, Spray Drying & Emerging Drying Technologies
Hotel Del Coronado
1500 Orange Ave. Coronado
San Diego, California
Optimizing Formulation, Cycle Development, Compliance and Scale-Up

This meeting covers latest trends and challenges in lyophilization, spray drying, foam drying and emerging drying technologies. It features in-depth case studies
and discussion on developing a scientifically sound formulation, process optimization, vaccine and biologics freeze/thaw and formulation challenges, strategies for
scale-up from R&D to production, and selection of container/closure systems.

Schedule of Presentations:

Tuesday, January 11, 2011
13:30:00 Conference Registration
14:00:00 BuzZ Session A | Interactive participation leads to problem-solving solutions and future collaborations around focused topics
14:45:00 Refreshment Break | Exhibit Viewing and Poster Awards
15:30:00 BuzZ Session B | Interactive participation leads to problem-solving solutions and future collaborations around focused topics
16:15:00 End of Day
16:30:00 Dinner Short Courses
Wednesday, January 12, 2011
07:00:00 Conference Registration
07:30:00 Breakfast Presentation | Morning Coffee
08:10:00 Freeze-Drying in Syringes
08:15:00 Chairperson’s Opening Remarks
08:20:00 The Impact of Container System on the Optimum Freeze-Drying Process: Contrasting Freeze-Drying in Syringes with Freeze-Drying in Vials Michael J. Pikal, Sajal Patel
09:00:00 Freeze-Drying In Syringes: Double-Chamber Cartridges Case Study
09:30:00 Meeting the Challenges in the Commercialization of Parenteral Products and Devices Fangdong Yin, Kurt Van Scoik
10:00:00 Coffee Break | Exhibit and Poster Viewing
10:40:00 Process Design Control and Validation
10:45:00 Process Design and Control in the Freezing Stage: Importance, Challenges and New Advancements Jinsong Liu
11:15:00 Facility Fit in Lyophilization: Optimizing Tech Transfer and Improving Overall Lyo Line Throughput Rick Johnston
11:45:00 Considerations for Scaling-Up Lyophilization Cycles from the Laboratory Scale to the Production Scale and for Transferring Lyophilization Cycles to Different Production Lyophilizers Willow DiLuzio
12:15:00 Close of Morning Session
12:30:00 Luncheon Presentations | Lunch on Your Own
13:55:00 Process Validation Based On QbD
14:00:00 Chairperson’s Remarks
14:05:00 Case Study: Lyophilization Process Validation Based on Quality by Design Bingquan (Stuart) Wang
14:35:00 The Fundamental Physics of Ice Crystallization Kenneth G. Libbrecht
15:05:00 Freeze-Dried Materials: Practical Questions and Fundamental Mechanisms Evgenyi Shalaev
15:35:00 Introduction of SP Scientific’s “LyoStar III” now with Praxair’s ControLyo™ On-Demand Ice Nucleation Technology Inside
15:50:00 Networking Refreshment Break
16:30:00 Exploring the Collapse Phenomenon during Lyophilization: When Is Collapse Acceptable? Serguei Tchessalov
17:00:00 Stabilization of Complex Biologicals by Freeze-Drying Under Unconventional Processing Conditions Satoshi Ohtake
17:30:00 Reception | Exhibit Hall
Thursday, January 13, 2011
07:30:00 Breakfast Presentation | Morning Coffee
08:10:00 Special Case Studies and Alternative Technology
08:15:00 Chairperson’s Opening Remarks
08:20:00 Freeze-Drying, Spray-Drying and Foam-Drying of Biologicals: A Comparison of the Impact of Thermal History on the Solid State Characteristics and Stability of Biopharmaceuticals Ahmad Abdul-Fattah
08:50:00 Engineering Cellular Microenvironments and Microstructures Brendan Harley
09:20:00 Impact of Lyophilizer Characteristics on Process Design and Scale-up Karen Bossert
09:50:00 Sponsored Presentation
10:05:00 Coffee Break | Exhibit Viewing and Poster Awards
10:45:00 Preparation of Protein Loaded Biodegradable Microparticles Using a Spray Dryer Fitted with a Coaxial Dual Flow Ultrasonic Atomizer Nozzle Tarun Mandal
11:15:00 Prediction of the Long-Term Chemical Stability of a Spray-Dried Insulin Powder for Inhalation via Structural Relaxation Modeling of Microcalorimetric Data Danforth Miller
11:45:00 Understanding Lyophilization Regulations: Being Prepared for FDA Audits & Review Issues Marc Père
12:15:00 Close of Morning Session
12:30:00 Luncheon Presentations | Lunch on Your Own
13:30:00 End of Conference
3D Tissue Models
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