学会の概要

Customize Your Learning Experience!

Mix-and-match sessions from these additional co-located conferences at no additional cost:

• Process & Product Validation
• Technology Transfer for Biopharmaceuticals
• Outsourcing Manufacturing of Biopharmaceuticals
• Viral Safety for Biologicals

Stay for the week so you can attend on Feb. 29 - March 2 for these conferences:

• Antibody Development & Production
• Recombinant Protein & Complex Biologic Development & Production
• Analytical Technologies for Biotherapeutic Development
• Biobetters & Biosimilars: Technologies & Development Strategies

Special Discounted Hotel Rate

Special Discounted Hotel Rate Available Until February 3, 2012.
To book your room, call 1-800-HILTONS and mention that you are an IBC attendee at this event.

プロセスのキャラクタリゼーションと理解のための手法が進化するなか、変動性の主な原因は原料であり、その影響は生物医薬品の開発と生産にも及んでいるという事実が統計上明らかになりつつあります。

この学会で取り上げるトピック

• 原料の変動性検査、キャラクタリゼーション、管理のための包括的な計画を策定するための戦略
• 培地／飼料の変更や加水分解といった上流工程での作業にまつわるリスクの軽減
• クロマトグラフィー樹脂や吸収剤のロットのばらつきなど下流工程にまつわる課題
• 複数の生産施設での利用を可能にする原料管理戦略の策定
• 外来性物質による原料汚染リスクの軽減
• サプライヤーから供給された原料の安全性と信頼性を確保するための戦略

特別講演

Development of a Raw Material Control Strategy for Use at Multiple Manufacturing Sites
Matt Osborne, Ph.D.
Cell Culture Technical Lead
Eli Lilly S.A., Ireland

Quality Management Best Practices in the Raw Material Supply Chain
Kimberly Carnes
Manager, Quality Assurance Compliance
Human Genome Sciences, Inc.

Strategies to Reduce Production Disturbances and Performance Variability Introduced by Raw Materials used in Product Manufacturing Operations
Victor J. Melendez Colon, Ph.D.
Principal Scientist, Process Development
Amgen Manufacturing, Limited, Puerto Rico

Assessment of Variability in Upstream Media and Feed Change and its Impact on Antibody Cell Line Performance and Quality Attributes
Abdul Wajid, Ph.D.
Senior Director, Process Sciences
XOMA (US) LLC