January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 
January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 

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Cambridge Healthtech Institute’s 9th Annual 
Lyophilization and Emerging Drying Technologies
Formulation Development, QbD, Process Optimization and
Delivery and Devices Challenges

January 19-20, 2016


The popular Lyophilization and Emerging Drying Technologies conference covers latest trends and challenges in lyophilization, spray drying, foam drying and emerging drying technologies. This conference features in-depth case studies, new and unpublished data and discussions on developing scientifically sound formulation, process optimization for biologics and vaccines.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, Quality by Design approaches and strategies for scale-up from Research & Development scale to full production level, and selection of container closure systems. We are seeking cutting-edge research findings and unpublished data to be featured at this forum.

We invite you to present a poster and join colleagues in this discussion of the key challenges and solutions in lyophilization and other drying technologies.

Preliminary Agenda 


QUALITY BY DESIGN (QbD) AND PAT IN FREEZE DRYING


KEYNOTE PRESENTATION
Freeze Dryer Operational Qualification to Allow Science Based Scale-Up and Quality by Design

Michael Pikal, Ph.D., Distinguished Endowed Chair in Pharmaceutical Technology & Professor of Pharmaceutics, University of Connecticut


Variation in Heat Flow to Vials within a Batch Is a Complex Function of Shelf Temperature and Chamber Pressure in a Laboratory Freeze-Dryer

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

Talk Title to be Announced

Alina A. Alexeenko, Ph.D., Assistant Professor, School of Aeronautics and Astronautics, Purdue University


ADVANCES IN LYOPHILIZATION
AND ALTERNATE DRYING TECHNOLOGIES

Freezing and Drying of Protein: What We Know, What We Think We Know, and What We Don’t Know

Evgenyi Shalaev, Ph.D., Research Investigator, Pharmaceutical Development, Allergan, Inc.

Microheterogeneity in Frozen and Desiccated Formulations

Alptekin Aksan, Ph.D., Associate Professor, Mechanical Engineering, University of Minnesota

Spray Drying and Freeze Drying of Liposomes and Nanoparticles

Tarun Mandal, Ph.D., McCaffrey/Norwood Endowed Professor of Pharmacy & Director, Center for Nanomedicine & Drug Delivery, College of Pharmacy, Xavier University of Louisiana

Atmospheric Spray-Freeze Drying (ASFD): A New Approach to Drying Pharmaceuticals

Thomas Robinson, M.D., Managing Director, Aerosol Therapeutics, LLC


OPTIMIZATION OF FREEZE-DRIED FORMULATIONS: CONTROLLED NUCLEATION, NEW TOOLS AND ELEGANCE ISSUES

Investigating Structure and Dynamics of Proteins in Amorphous Phases Using Neutron Scattering

Joseph E. Curtis, Ph.D., Research Chemist, Condensed Matter Science Group, NIST Center for Neutron Research, National Institute of Standards and Technology

Lyophilized Drug Product Cake Appearance – What Is Acceptable?

Sajal M. Patel, Ph.D., Senior Scientist, Formulation Sciences, Biopharmaceutical Development, MedImmune

Application of Controlled Nucleation during Lyophilization to Improve Cake Appearance and Protein Stability

Bingquan (Stuart) Wang, Ph.D., Senior Scientist, Technical Development, Biogen

MillrockPresentation to be Announced

T.N. Thompson, President, Millrock Technology, Inc.


Estimation of Shelf Life Stability Based on Fast Dynamics of Lyophilized Protein Formulations

Ken K. Qian, Ph.D., Research Chemist and NIST-MedImmune Fellow, Biomaterials Group, National Institute of Standards and Technology

Talk Title to be Announced

Charlie (Xiaolin) Tang, Ph.D., Associate Director, Formulation Development, Regeneron Pharmaceuticals, Inc.




For questions about the meeting, please contact:

Micah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute
Phone: 541-482-4709
Email: mlieberman@healthtech.com 

For partnering & sponsorship information, please contact: 

Companies A-K
Jason Gerardi
Manager, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5452
Fax: 781-972-5470
Email: jgerardi@healthtech.com 

Companies L-Z
Carol Dinerstein
Director, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5471
Fax: 781-972-5470
Email: dinerstein@healthtech.com