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Download
2008 Final Brochure
Learn from the Real World Experience of Industry Members Working in Formulation, Cycle Development, and Manufacturing!
This three-day
lyophilization event will take place within CHI’s
PepTalk –
The Definitive Protein-Focused Event. "Lyophilization"
will feature novel case studies and in-depth
presentations from industry thought leaders. It
is perfect for those who require in-depth
analysis of the latest trends, technologies, and
techniques, as well as those new to the field.
- Regulatory and Compliance Issues: Being
Prepared for FDA Inspections
- Freeze Dryer Selection: Best Practices and
Lessons Learned
- Factory Acceptance Testing (FAT) and
Future Validation
- Developing a Scientifically Sound
Formulation and Optimizing the Lyo Process
- Points to Consider on Freeze Drying
Process Design for Scale-Up
- A Gentle PAT Approach to In-Line Control
of the Lyophilization Process
- Selection of Container/Closure Systems for
Lyophilization of Biological Products
- Root Cause Analysis and Risk Assessment
for Lyophilized Product
- Matrix Validation Approaches for
Lyophilized Products
| In-Depth
Industry Case Studies and Workshops by: |
| Allergan
Amgen
Aridis Pharmaceuticals
Baxter BioScience
BioConvergence LLC
Centocor, Inc. (J&J)
Genentech, Inc.
GlaxoSmithKline Biologicals
IMA-Telstar, S.L. |
Leiden
University
Lyophilization Technology, Inc.
MedImmune, Inc.
Merck & Co., Inc.
Millennium Pharmaceuticals
Pfizer Inc.
Qualification Process Solutions,
LLC
W.L. Gore & Associates, Inc. |
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Special Pre-Conference Workshops
Wednesday, January 9, 2008
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Elements of a
High Quality Aseptic Filling Program
Robert J. Pallo, BA, MAM, Manager, PSO
Fill and Finish Operations, Allergan
Lyophilization
Fundamentals—Understanding the Basic Concepts
and Processes
Edward H. Trappler, Presdient &
Founder, Lyophilization Technology, Inc.
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