Biological Assay Development & Validation

Event Information

Exploration of the Tools You Need for Robust and Reliable Assays

Biological Assay Development & Validation 2010
(生物检定的开发及有关验证的学会)

2010年5月12 - 14日 · Sheraton Fisherman's Wharf · 加利福尼亚州旧金山

本学会概要

本学会概要

Biological Assay Development & Validation是把重点放在生物检定领域最具悠久历史的技术面之学界。迷你个别指导、实践性的研究会,在以独特形式组成丰富多彩的个案研究等之本学会中,聚齐有助业务效率化的所有要素。

邀请演讲
制剂考试用生物检定:其优点与规定
亦为各位介绍拍摄效力检定时细胞状态的珍贵影像
Thomas Waerner, Ph.D., Head of Cell & Molecular Biology, Quality & Compliance, Boehringer Ingelheim RCV GmbH & Co KG, Germany

今年学会的特徵

  • 选择重要性高之稀少试剂后的保存是件困难的工作。今年学会将介绍有助于回避与该项作业有关纠纷的个案研究。
  • 能加深对有关采用quality by design (QdB)手法使开发作业迅速化的方法之理解—EU方法的个案研究及最新信息
  • 介绍使用实验计划(DOE)手法进行分析、评估开发日程改善方法之个案研究
  • 介绍回避起因于恶劣制模之一般性纠纷的策略—Amgen公司及Precision Bioassay公司的代表者给予实践性的建议
  • 预定进行以比较生物检定统计性方法为主题的迷你个别指导,在向规制当局提出建议书之前的阶段,能加深对重要要求条件的理解
  • 为各位介绍透过2个成功例子的实践性个案研究,确实促进分析、评估转换作业的方法
  • 美国药典(USP)生物检定委员会的会长将介绍最新倾向。预定也将网罗今年5月发表之USP的章节。
  • 透过开发以分析、评估抗体依存性细胞障碍作用(ADCC)及结合效力检定之新方法为主题的3个个案研究,能获得有助于筹划开发计划的新想法
  • 亦预定介绍被视为最难开发之宿主细胞原有蛋白质分析、评估的开发方法

再则,今年的研究会亦预定讨论其他学会无法采用的下述困难主题

  • 分析生物检定的异常值
  • 判断计量的界限
  • 监视使用了统计工程管理(SPC)手法之分析与评估
  • 实证依据Brand-Altman method来进行分析与评估比较之可能性

参会者见证

"I found this conference extremely useful. Many of the topics covered in the talks were directly applicable to my work in analytical assay development."
- Joni Castro, Senior Development Associate Process Development, OncoMed Pharmaceuticals

"This conference has provided a broad scope of prospective for me and has opened my eyes to a lot of 'what not to do'!"
- Fouzia Farood, Research Tech/Flow Cytometrist, Malaria, Walter Reed Army Research Institute/NMRC

"The best thing is the variety and the opportunity of contact with the different "sides" of this area (regulators, manufacturers) CRO"
- Alicia Jiminez, Researcher, CBER/FDA, LRSP/DBPAP

"Each time I attend this conference, I broaden my understanding of the challenges and solutions in this industry."
- L. McNeill

"The best and most directly applicable information for our industry presented by industry leaders and newcomers alike. A most valuable resource."
- R. Lowe

"An interesting and entertaining interface between biologists and statisticians. I would have loved to have all this information six months ago, and I greatly appreciate having it now."
- M. Woodrow

"The information presented was illuminating, entertaining and informative so that even a statistician with almost no biological background could understand it."
- R. Eyben

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