學會概要

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.

在製程的特性描述和理解的手法進化中，變動性主要的原因是原料，依據統計可知其影響生物醫藥品的開發及生產為不爭的事實。

學會處理的話題

• 檢查原料的變動性、特性描述、制定管理的總括性計劃之策略
• 減輕變更培養基/飼料及加水分解之上游工程作業的風險
• 與層析法樹脂和吸收劑的批量偏差等下游工程有關的課題
• 制定複數生產設施可利用的原料管理策略
• 減輕外來性物質的原料污染風險
• 為了確保供應商供應的原料之安全性和可靠性的策略

特別演講

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