冻结乾燥会议 - 概要

概要 | Day 1 | Day 2 | Day 3

议程 (PDF : English)

本会议将邀请制剂设计、周期发展、制造实务相关负责人相互交流及讨论实际经验。与会者在会议中还将有机会聆听业界意见领袖的新个案研究及详细内容发表。无论是对于新进入该产业的企业或是已掌握充份知识的企业而言，这都是学习最新趋势、技术、技巧的绝佳机会。

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乫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.