凍結乾燥に関する会議 - 概要

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アジェンダ (英語PDF)

製剤設計、サイクル開発、製造に携わる実務担当者が集い、実際の経験に基づいた議論を行います。

業界のオピニオンリーダーによる新たなケーススタディと詳細なプレゼンテーションが提供されます。

この業界に新規参入する方、また逆に詳細な知識を持つ方両方にとって、最新のトレンド、技術、テクニックについて学ぶよい機会です。

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.