PepTalk 2017
PepTalk 2017

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Cambridge Healthtech Institute‚Äôs Tenth Annual 
Lyophilization and Emerging Drying Technologies
Formulation and Process Optimization, QbD, Process and Scale-Up Challenges
January 10-11, 2017 | Hilton San Diego Bayfront | San Diego, CA


The popular Tenth Annual Lyophilization and Emerging Drying Technologies conference covers latest trends and challenges in lyophilization 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 This conference features in-depth case studies, new and unpublished data and discussions on developing scientifically sound formulation, process optimization for biologics and vaccines.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, QbD and PAT approaches and strategies for scale-up from R&D scale to full production level, and selection of container closure systems.

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

Preliminary Agenda


QbD, PAT, PROCESS SCALE-UP AND TECH TRANSFER

Resolving Scale-Up Problems in Freeze Drying: Differences in Dry Layer Resistance and in Effective Vial Heat Transfer Coefficients

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

An Industry Prospective on Application of Modeling to Lyophilization Process Scale-Up and Transfer

Serguei Tchessalov, Ph.D., Associate Research Fellow, Bio Therapeutics R&D, Pfizer

New Case Studies and Strategies for Manufacturing, Scale-Up and Tech Transfer

Alexander P. Herbert, Senior Process Engineer, Process Engineering and Pilot Plant, West-Ward Pharmaceuticals

Innovative Approaches for Lyophilization Process, Equipment and Drug Product Characterization

Ahmad M. Abdul-Fattah, Ph.D., Senior Scientist, Lyophilization Unit, Coriolis Pharma


ROLE OF WATER AND ICE

Role of Water in Chemical Instability of Freeze-Dried Proteins: Plasticization vs. Water Catalysis

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

Mobility and Water-Dependent Chemical Reaction Pathways in Lyophilized Formulations of Peptides and Proteins

Bradley D. Anderson, Ph.D., Professor, Pharmaceutical Sciences, University of Kentucky


MODELS AND TOOLS

Modeling the Secondary Drying Stage of Freeze Drying: Development and Validation of an Excel-Based Model

Ekneet Sahni, Ph.D., Senior Process Development Engineer, Manufacturing Science and Technology (MSAT), Pfizer

Bench-Top Methods for Predicting Stability of Freeze-Dried Proteins

Marcus T. Cicerone, Ph.D., Biomaterials Group, National Institute of Standards and Technology




For questions about the meeting, please contact:

Nandini Kashyap
Conference Director
Cambridge Healthtech Institute
Phone: 781-972-5406
Email: nkashyap@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