Lyophilization 2005 - May 18-20, 2005

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Barnett International's Annual Conference on Freeze-Drying
Lyophilization 2005
Strategies for Successful Formulation, Cycle Development and
Optimization, Regulatory Compliance, Validation, and Scale-Up
- May 18-20, 2005 - Washington Marriott - Washington, DC
L e a r n f r o m t h e R e a l Wo r l d E x p e r i e n c e o f I n d u s t r y M e m b e r s
Wo r k i n g i n F o r m u l a t i o n , C y c l e D e v e l o p m e n t , a n d M a n u f a c t u r i n g !
Eli Lilly and Company
Chiron Corporation
Regeneron Pharmaceuticals, Inc.
Lyophilization Technology, Inc.
BOC Edwards Pharmaceutical Systems
Sublimation Science
FTS Systems, Inc.
Baxter Pharmaceutical Solutions, LLC
Sanofi Pasteur
GlaxoSmithKline Biologicals
KBI BioPharma, Inc.
QLT USA, Inc.
SP Industries-VirTis & Hull Brands
Microbiological Consulting
TELSTAR Industrial, S.L.
Genentech, Inc.
US Food and Drug Administration, CBER
I n - D e p t h I n d u s t r y C a s e S t u d i e s a n d Wo r k s h o p s :
An Empirical Approach to Developing
an Optimized Lyophilization Cycle:
Formulation and Process Strategies
J. Jeff Schwegman, PhD,
Baxter Pharmaceutical Solutions, LLC
Comprehensive Process Validation &
Use of Microbalance to Develop a
Freeze-Drying Cycle
Yves Mayeresse, GlaxoSmithKline Biologicals
Knowing and Fully Utilizing
Your Freeze-Dryer?s Maximum
Throughput Capability
Jim Searles, PhD, Eli Lilly and Company
Being Prepared for
FDA Inspections
of Lyophilized Products
Robert Darius,
US FDA, CBER
Successful Scale-Up from Pilot Scale
to Production Scale & Selecting a
Contract Site
Samir U. Sane, PhD, Genentech, Inc.
Developing a Scientifically Sound
Formulation and Optimizing the
Lyophilization Process
Agnieszka Banbula, PhD, KBI BioPharma, Inc.
An Interactive Tutorial and Closing Workshop on:
Risk Assessment and Root Cause Analysis in the Lyophilization Process
Edward H. Trappler, Lyophilization Technology, Inc.