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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.

Preliminary Agenda 


KEYNOTE PRESENTATION  

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 


LYOPHILIZED FORMULATION DEVELOPMENT AND PROTEIN STABILITY 

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.  


ADVANCES IN LYOPHILIZATION AND ALTERNATE DRYING TECHNOLOGIES 

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 

SP ScientificEffect 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. 


LYO PROCESS DEVELOPMENT: QbD, SCALE-UP AND DESIGN SPACE 

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 CHALLENGES:  DUAL CHAMBER CONTAINERS, SYRINGES AND GLASS VIAL 

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 


POST-PROCESS ANALYSIS: THERMAL ANALYSIS, CAKE PROPERTIES AND RECONSTITUTION 

Measurement of Vial Heat Transfer Coefficients: Nuances and Pitfalls 

Robin Bogner, Ph.D., Associate Professor, School of Pharmacy, University of Connecticut