Cambridge Healthtech Institute’s 8th Annual
Lyophilization and Emerging Drying Technologies
Formulation Development, Process Optimization, Validation
and Regulatory Compliance
January 21-22, 2015
This popular conference covers latest trends and challenges in lyophilization, spray drying, foam drying and emerging drying technologies. The Lyophilization and Emerging Drying Technologies conference features in-depth case studies and discussion on developing scientifically sound formulation, process optimization for biologics and vaccines. It also presents cutting-edge research and case studies on freeze/thaw and formulation challenges, drying in cartridges, storage stability and strategies for scale-up from R&D scale to full production level, tech transfer and selection of container/closure systems.
We invite you to join colleagues in this discussion of the key challenges and solutions in lyophilization and other drying technologies, and see how experts like you are developing a scientifically sound formulation to deliver a safe and stable biologic drug product.
Neglected Factors in Stabilization of Proteins by Freeze Drying
Michael J. Pikal, Ph.D., Pfizer Distinguished Endowed Chair, Pharmaceutical Technology; Professor, Pharmaceutics, School of Pharmacy, University of Connecticut
The Role of Physical Chemistry in Freeze Drying – From Product Characteristics to Process Performance
Timothy R. McCoy, M.Sc., Principal Scientist, Technical Development, Genzyme
Case Study on Lyophilized Formulation Development
Charlie (Xiaolin) Tang, Ph.D., Associate Director, Formulation Development, Regeneron Pharmaceuticals, Inc.
Use of Microwave Vacuum Drying as an Alternative to Lyophilization of Vaccines and Biologics
Justin Stanbro, Ph.D., Associate Principal Scientist, Novel Adjuvants, Formulation & Delivery Technologies, Merck & Co.
A Critical Eye on Controlled Nucleation in Freeze Drying of Protein Drugs
Gerhard Winter, Ph.D., Professor, Chair, Pharmaceutical Technology and Biopharmaceutics, LMU Munchen
Effect of Nucleation Temperature on Protein Aggregation, Folding and Presence of Sub-Visible Particles
Mark Shon, MBA, Vice President, Technology Development, SP Scientific
Jeff Schwegman, Ph.D., CEO, AB Biotechnologies
Applications of Controlled Ice Nucleation for Difficult to Lyophilize Products
Graham Magill, Associate Engineer, Pharmaceutical Processing and Tech. Development, Genentech, Inc.
Talk Title to Be Announced
Alina A. Alexeenko, Ph.D., Assistant Professor, School of Aeronautics and Astronautics, Purdue University
Primary Drying Optimization Using a Three-Dimensional Design Space
Lindsay Wegiel, Ph.D., Research Associate III, Pharmaceutical R&D, Baxter Healthcare Corporation
Lyophilization of Pharmaceuticals in Dual Chamber Containers (DCC): Challenges during Process Scale Up (Case Studies)
Serguei Tchessalov, Ph.D., Associate Research Fellow, Biotherapeutics Pharmaceutical Research & Development, Pfizer, Inc.
Lyophilized Drug Product Fogging Onto the Glass Vial: Problem and Solution
Mark Yang, Ph.D., Director, Fill Finish Development, Commercial Process Development, Genzyme
Measurement of Vial Heat Transfer Coefficients: Nuances and Pitfalls
Robin Bogner, Ph.D., Associate Professor, School of Pharmacy, University of Connecticut