学会概要

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.

在制程的特性描述和理解的手法进化中，变动性主要的原因是原料，依据统计可知其影响生物医药品的开发及生产为不争的事实。

学会处理的话题

• 检查原料的变动性、特性描述、制定管理的总括性计划之策略
• 减轻变更培养基/饲料及加水分解之上游工程作业的风险
• 与层析法树脂和吸收剂的批量偏差等下游工程有关的课题
• 制定复数生产设施可利用的原料管理策略
• 减轻外来性物质的原料污染风险
• 为了确保供应商供应的原料之安全性和可靠性的策略

特别演讲

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