凍結乾燥會議 - 概要

概要 | Day 1 | Day 2 | Day 3

議程 (PDF : English)

本會議將邀請製劑設計、周期發展、製造實務相關負責人相互交流及討論實際經驗。與會者在會議中還將有機會聆聽業界意見領袖的新個案研究及詳細內容發表。無論是對於新進入該產業的企業或是已掌握充份知識的企業而言，這都是學習最新趨勢、技術、技巧的絕佳機會。

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�fs 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.