Outsourcing Manufacturing of Biopharmaceuticals（生物医药品制造业务的外包）
CSS
学会概要
Mix-and-match sessions from these additional co-located conferences at no additional cost:
- Process & Product Validation
- Technology Transfer for Biopharmaceuticals
- Biopharmaceutical Raw Materials throughout the Product Lifecycle
- Viral Safety for Biologicals
Stay for the week so you can attend on Feb. 29 - March 2 for these conferences:
此学会为减轻风险策略及发展业务优越性，继续监督供应链的安全性和原料的可靠性，维持接受订货者和订购者的良好关系，以及表明使医药品制造受托机关(CMO)供应的产品维持品质的见识。
- 回应符合监查和品质控制－订购者的期待
- 与CMO合作改善生产制程
- 共同开发细胞疗法的可能性
- 利用模拟工具的最适合资源制订计划和生产设施的利用
- 委托生产的业务优越性和应用业绩评价
- 原料的评价和认定适正性：从开发转向商业化
重点演讲
Biologics Product & Process Lifecycle Management: Genentech / Roche Experience
David Chang, Ph.D.
Senior Director, Global Biologics Manufacturing Science & Technology
Genentech, Inc., a member of the Roche group
Facility Fit Analysis – The First Step in a Long Journey
Greg Liposky, Ph.D.
Vice President & General Manager, Site Operations
MedImmune
特别演讲
Improving the Manufacturing Process Of CER-001, A Recombinant Human Apolipoprotein A-I HDL Mimetic
Jean-Louis Dasseux, Ph.D.
Chief Executive Officer
Cerenis Therapeutics
2012年计画值得一看的地方
- 符合监查和品质管理
- 与CMO共同开发之技术的改善和革新
- 生产设施最适化的建模/模拟工具
- 技术移转时维持良好的合作关系
- 委托外部生产的策略和重要业绩评价指标(KPI)的判断
- 供应链的危机管理
- 对供应商供应的原料之评价和品质控制